# FDA General Hospital device clearances: 378 since Nov 2024

Updated October 30, 2026.

FDA made 378 device decisions in general hospital (FDA review panel) from November 12, 2024 to October 30, 2026: 339 510(k) clearances and De Novo grants and 39 PMA approvals and supplements, for 230 applicants. The newest, P860004/S465 on October 30, 2026, is SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters from Medtronic, Inc..

## The full list

FDA general hospital device clearances and approvals: 378 rows for $18.90, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 13 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/panel/general-hospital

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 378
- 510(k) and De Novo: 339
- PMA: 39
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 378, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | P860004/S465 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S465) |
| October 30, 2026 | K260354 | Foster Plus-22L (SNK/CE-F22) | Zhejiang Fomos Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FLE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260354) |
| October 29, 2026 | P860004/S464 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters TDD (Drug Delivery Infusion Pump 8667), TDD (Drug... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S464) |
| October 29, 2026 | K263530 | V-Pro maX 2 Low Temperature Sterilization System | Steris | Ohio | Substantially Equivalent | 510(k) special | MLR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263530) |
| October 29, 2026 | K260427 | Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+) | Lumicare Medtech Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | SCS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260427) |
| October 29, 2026 | K253508 | Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile | Vietglove Corporation | Vietnam | Substantially Equivalent | 510(k) traditional | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253508) |
| October 28, 2026 | K260822 | VERIFY RESI-TEST SWAB Protein Detection Indicator | Steris | Ohio | Substantially Equivalent | 510(k) traditional | SDC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260822) |
| October 27, 2026 | P860004/S458 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters | Medtronic, Inc. | Minnesota | Approved | PMA 180-day supplement | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S458) |
| October 22, 2026 | K262084 | S.I.N. Instruments Kits | S.I.N. Implant System Ltda | Brazil | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262084) |
| October 22, 2026 | K260261 | Gravity Blood Sets with 200µm Filter | B.Braun Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260261) |
| October 16, 2026 | P860004/S462 | SynchroMed™ Infusion System, Ascenda ™ Intrathecal Catheters | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S462) |
| October 16, 2026 | K263267 | Endox Test Strips | Ibt Scientific | North Carolina | Substantially Equivalent | 510(k) traditional | JOJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263267) |
| October 16, 2026 | K260180 | Carecube Negative Pressure Isolation Chamber (1BY) | Carecubes, Inc. | California | Substantially Equivalent | 510(k) traditional | LGM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260180) |
| October 16, 2026 | K254094 | Endox High Level Disinfectant | Whiteley USA, Inc. | Delaware | Substantially Equivalent | 510(k) traditional | MED | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254094) |
| October 14, 2026 | K262042 | Sterilization Cassette (CASS-1) | Alliedstar Medical Equipment Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262042) |
| October 9, 2026 | K260080 | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler | Medical Components, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | LJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260080) |
| October 6, 2026 | K262516 | TSK OptiXion | Tsk Laboratory, Japan | Japan | Substantially Equivalent | 510(k) traditional | QYM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262516) |
| October 1, 2026 | K262208 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use... | Yty Industry (Manjung) Sdn Bhd | Malaysia | Substantially Equivalent | 510(k) traditional | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262208) |
| September 25, 2026 | K261992 | 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | Texas | Substantially Equivalent | 510(k) traditional | JOJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261992) |
| September 18, 2026 | K262532 | NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | ICU Medical | Illinois | Substantially Equivalent | 510(k) traditional | LGZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262532) |
| September 18, 2026 | K254095 | 25G Huber Needle | Martech Medical Products | Pennsylvania | Substantially Equivalent | 510(k) traditional | PTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254095) |
| September 17, 2026 | K261266 | MOWANA™ Auto Duo | Pentamaster Mediq Sdn Bhd | Malaysia | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261266) |
| September 11, 2026 | K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | Illinois | Substantially Equivalent | 510(k) abbreviated | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254123) |
| September 9, 2026 | K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination... | Top Glove Sdn. Bhd. | Malaysia | Substantially Equivalent | 510(k) special | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262542) |
| September 9, 2026 | K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and... | Maxter Healthcare, Inc. | Texas | Substantially Equivalent | 510(k) traditional | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261793) |
| September 8, 2026 | K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation... | Gmp Medicare Sdn. Bhd. | Malaysia | Substantially Equivalent | 510(k) special | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260312) |
| September 8, 2026 | K253988 | LiteSet Trays | Nobel Biocare AB | Sweden | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253988) |
| September 4, 2026 | K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261935) |
| September 2, 2026 | K262153 | Pivot Insulin Delivery System | Modular Medical, Inc. | California | Substantially Equivalent | 510(k) traditional | LZG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262153) |
| September 2, 2026 | K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Cardinalhealth | Illinois | Substantially Equivalent | 510(k) traditional | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261749) |
| September 2, 2026 | K260432 | Ruby Intravascular Catheter | Venocare, Inc. | Florida | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260432) |
| August 31, 2026 | K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | Global Life Sciences Solutions USA, LLC | Massachusetts | Substantially Equivalent | 510(k) traditional | FPB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261403) |
| August 26, 2026 | K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) special | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262581) |
| August 25, 2026 | K261719 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | China | Substantially Equivalent | 510(k) special | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261719) |
| August 25, 2026 | K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252184) |
| August 21, 2026 | P860004/S461 | SynchroMed™ III Pump Drug Delivery Infusion Pump | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S461) |
| August 19, 2026 | DEN250046 | Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US) | Vitestro | Netherlands | Unknown | De Novo | SIW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250046) |
| August 18, 2026 | K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR... | Kossan International Sdn Bhd | Malaysia | Substantially Equivalent | 510(k) traditional | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260794) |
| August 14, 2026 | K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253747) |
| August 13, 2026 | P860004/S460 | SynchroMed Infusion System, Ascenda Intrathecal Catheters | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S460) |
| August 10, 2026 | K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety... | Hh Global Technology, Inc. | Georgia | Substantially Equivalent | 510(k) special | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262427) |
| August 10, 2026 | K260165 | Unimpregnated Central Venous Catheter | Spectrum Vascular | New York | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260165) |
| August 8, 2026 | P860004/S459 | SynchroMed™ Infusion System; Ascenda™ Intrathecal Catheters | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S459) |
| August 7, 2026 | K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R... | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260933) |
| August 5, 2026 | K260845 | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | MMK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260845) |
| August 4, 2026 | K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | California | Substantially Equivalent | 510(k) traditional | MRH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253760) |
| July 29, 2026 | K261829 | Profoject™ Dual-Safety Pen Needles | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261829) |
| July 28, 2026 | K260326 | Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | Wisconsin | Substantially Equivalent | 510(k) traditional | FMZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260326) |
| July 24, 2026 | K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | New Hampshire | Substantially Equivalent | 510(k) traditional | FRN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253703) |
| July 21, 2026 | K262014 | PUREZERO\* MARIN\* Nitrile Powder-Free Exam Gloves; PUREZERO\* MARIN-XTRA\* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) special | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262014) |
| July 20, 2026 | K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder... | Hartalega NGC Sdn. Bhd. | Malaysia | Substantially Equivalent | 510(k) special | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254285) |
| July 15, 2026 | K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260739) |
| July 13, 2026 | K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | New Jersey | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260208) |
| July 10, 2026 | K261041 | ClearSafe Closed System | MedSource Labs, LLC | Minnesota | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261041) |
| July 9, 2026 | K260539 | MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter | MedSource Labs, LLC | Minnesota | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260539) |
| July 2, 2026 | K261897 | HALYARD\* ARMOR-FLEX\* Sterilization Wrap with ASSURE-DRY\* Technology; HALYARD\* HEAVY-FLEX\* Sterilization Wrap... | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | FRG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261897) |
| July 1, 2026 | K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload... | Covidien, LLC | Connecticut | Substantially Equivalent | 510(k) traditional | GAG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253527) |
| June 24, 2026 | K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) traditional | FLE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261055) |
| June 24, 2026 | K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs... | Sw Technologies, Inc. | California | Substantially Equivalent | 510(k) special | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252117) |
| June 18, 2026 | K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | Vietnam | Substantially Equivalent | 510(k) traditional | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253824) |
| June 18, 2026 | K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | South Dakota | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253187) |
| June 18, 2026 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253110) |
| June 18, 2026 | K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | Ohio | Substantially Equivalent | 510(k) traditional | QVB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251559) |
| June 17, 2026 | K260916 | FLEXI-PORT™ Power Injectable Implantable Port | Portal Access, Inc. | Florida | Substantially Equivalent | 510(k) traditional | LJT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260916) |
| June 17, 2026 | K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)... | Hartalega NGC Sdn. Bhd. | Malaysia | Substantially Equivalent | 510(k) special | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260867) |
| June 12, 2026 | K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with... | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260514) |
| June 12, 2026 | K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | PQH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253688) |
| June 12, 2026 | K252987 | ADRx™ Admixture Device | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | LHI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252987) |
| June 10, 2026 | K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260855) |
| June 5, 2026 | K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | LHI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260301) |
| June 5, 2026 | K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes... | Unimed Medical Supplies, Inc. | China | Substantially Equivalent | 510(k) traditional | FLL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253162) |
| June 3, 2026 | K261530 | iiSure Infusion Set | Deka Research and Development | New Hampshire | Substantially Equivalent | 510(k) special | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261530) |
| June 3, 2026 | K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | California | Substantially Equivalent | 510(k) traditional | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260806) |
| June 3, 2026 | K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | Switzerland | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260726) |
| June 3, 2026 | K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free... | S&S Glove Corporation | Vietnam | Substantially Equivalent | 510(k) traditional | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260703) |
| June 3, 2026 | K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | New Jersey | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252854) |
| May 28, 2026 | K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | New York | Substantially Equivalent | 510(k) traditional | FRG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252823) |
| May 22, 2026 | K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA)... | Taizhou Huangyan Guanhong Plastic Steel Products Factory | China | Substantially Equivalent | 510(k) traditional | MMK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253773) |
| May 21, 2026 | K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter... | Hlb Lifescience Co., Ltd. | South Korea | Substantially Equivalent | 510(k) special | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253112) |
| May 18, 2026 | K253454 | HALYARD\* ONE-STEP\* Sterilization Wrap; HALYARD\* QUICK CHECK\* Sterilization Wrap; HALYARD\* SEQUENTIAL... | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | FRG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253454) |
| May 15, 2026 | K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253235) |
| May 4, 2026 | K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF... | Amsino International, Inc. | California | Substantially Equivalent | 510(k) traditional | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252543) |
| May 1, 2026 | DEN240075 | Prolystica Pass Thru Disinfectant Wipes | Steris | Ohio | Unknown | De Novo | SHM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN240075) |
| April 30, 2026 | K250680 | Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | New York | Substantially Equivalent | 510(k) traditional | SAK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250680) |
| April 29, 2026 | K252471 | Paptizer 360 | LiViliti Health Products Corporation | Florida | Substantially Equivalent | 510(k) traditional | QXQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252471) |
| April 24, 2026 | K260988 | °M Warmer System with °M Station | Mequ A/S | Denmark | Substantially Equivalent | 510(k) special | LGZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260988) |
| April 24, 2026 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | MEB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250234) |
| April 22, 2026 | K252306 | Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD)... | Steritec Products | Colorado | Substantially Equivalent | 510(k) traditional | QVB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252306) |
| April 20, 2026 | K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | Virginia | Substantially Equivalent | 510(k) traditional | LZH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253558) |
| April 17, 2026 | K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | Australia | Substantially Equivalent | 510(k) special | LJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260929) |
| April 17, 2026 | K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | Slovakia | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252279) |
| April 16, 2026 | K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | China | Substantially Equivalent | 510(k) special | FMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254273) |
| April 15, 2026 | K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | California | Substantially Equivalent | 510(k) traditional | MLR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252843) |
| April 10, 2026 | K252757 | CeQur Simplicity™ On-Demand Insulin Delivery System | Cequr SA | Switzerland | Substantially Equivalent | 510(k) special | OPP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252757) |
| April 8, 2026 | K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) special | FRC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260766) |
| April 8, 2026 | K253534 | Pivot Insulin Delivery System | Modular Medical | California | Substantially Equivalent | 510(k) traditional | LZG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253534) |
| April 8, 2026 | K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant... | STERIS Corporation | Ohio | Substantially Equivalent | 510(k) traditional | MED | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251666) |
| April 7, 2026 | K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. | California | Substantially Equivalent | 510(k) traditional | LYZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260860) |
| April 2, 2026 | K252137 | BD Insyte™ IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252137) |
| April 2, 2026 | K252130 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | Illinois | Substantially Equivalent | 510(k) traditional | PHC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252130) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Medtronic, Inc. | 33 | October 30, 2026 |
| STERIS Corporation | 9 | June 24, 2026 |
| CMT Health PTE., Ltd. | 8 | July 29, 2026 |
| Epic Medical Pte. , Ltd. | 8 | June 12, 2026 |
| Basic Medical Technology, Inc. | 8 | April 7, 2026 |
| Icu Medical, Inc. | 8 | April 2, 2026 |
| Promisemed Hangzhou Meditech Co., Ltd. | 6 | August 25, 2026 |
| O&M Halyard, Inc. | 6 | July 21, 2026 |
| Becton Dickinson Infusion Therapy Systems, Inc. | 6 | April 2, 2026 |
| Steris | 5 | October 29, 2026 |
| Hartalega NGC Sdn. Bhd. | 5 | July 20, 2026 |
| Spectrum Vascular | 4 | August 10, 2026 |
| Intera Oncology | 4 | March 16, 2026 |
| Access Vascular, Inc. | 4 | August 1, 2025 |
| Baxter Healthcare Corporation | 4 | July 28, 2025 |
| B.Braun Medical, Inc. | 3 | October 22, 2026 |
| Tsk Laboratory, Japan | 3 | October 6, 2026 |
| Dentsply Sirona, Inc. | 3 | September 4, 2026 |
| Cardinalhealth | 3 | September 2, 2026 |
| Sol-Millennium Medical, Inc. | 3 | August 25, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 258 | October 30, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 67 | October 29, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 25 | October 30, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 8 | September 11, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 6 | October 27, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 6 | August 19, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 4 | August 29, 2025 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 2 | February 26, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 2 | January 20, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 41 | October 30, 2026 |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 39 | October 16, 2026 |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 37 | October 30, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 21 | September 18, 2026 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 17 | October 29, 2026 |
| [Malaysia](https://specstream.ai/data/fda-clearances/country/malaysia) | 17 | October 1, 2026 |
| [Singapore](https://specstream.ai/data/fda-clearances/country/singapore) | 16 | July 29, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 15 | August 31, 2026 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 12 | October 22, 2026 |
| [Utah](https://specstream.ai/data/fda-clearances/state/utah) | 12 | April 2, 2026 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 10 | July 13, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 9 | September 2, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 9 | August 10, 2026 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 8 | October 16, 2026 |
| [New Hampshire](https://specstream.ai/data/fda-clearances/state/new-hampshire) | 7 | July 24, 2026 |
| Vietnam | 6 | October 29, 2026 |
| [Georgia](https://specstream.ai/data/fda-clearances/state/georgia) | 6 | August 10, 2026 |
| [Switzerland](https://specstream.ai/data/fda-clearances/country/switzerland) | 6 | June 3, 2026 |
| [Japan](https://specstream.ai/data/fda-clearances/country/japan) | 5 | October 6, 2026 |
| [South Korea](https://specstream.ai/data/fda-clearances/country/south-korea) | 5 | May 21, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 4 | September 25, 2026 |
| [Netherlands](https://specstream.ai/data/fda-clearances/country/netherlands) | 4 | August 19, 2026 |
| [Wisconsin](https://specstream.ai/data/fda-clearances/state/wisconsin) | 4 | July 28, 2026 |
| [Virginia](https://specstream.ai/data/fda-clearances/state/virginia) | 4 | April 20, 2026 |
| [Australia](https://specstream.ai/data/fda-clearances/country/australia) | 4 | April 17, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).