# FDA 510(k) abbreviated decisions: 76 since Nov 2024

Updated October 21, 2026.

FDA made 76 device decisions of type 510(k) abbreviated from November 15, 2024 to October 21, 2026: 76 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 60 applicants. The newest, K261788 on October 21, 2026, is Eden PACS from Higia., Inc. d/b/a Eden.

## The full list

FDA 510(k) abbreviated decisions: 76 rows for $5, 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 3 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, decision type, date received and 6 more), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-clearances/decision/510k-abbreviated

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: 76
- 510(k) and De Novo: 76
- PMA: 0
- Latest decision: October 21, 2026

## Newest decisions

The newest 76 of 76, 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 21, 2026 | K261788 | Eden PACS | Higia., Inc. d/b/a Eden | Delaware | Substantially Equivalent | 510(k) abbreviated | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261788) |
| October 6, 2026 | K260136 | Forza | True Function Laboratory, Inc. | California | Substantially Equivalent | 510(k) abbreviated | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260136) |
| September 17, 2026 | K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | California | Substantially Equivalent | 510(k) abbreviated | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261392) |
| 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 4, 2026 | K253529 | Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | New York | Substantially Equivalent | 510(k) abbreviated | MWJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253529) |
| September 1, 2026 | K262783 | RadiForce MX247W | Eizo Corporation | Japan | Substantially Equivalent | 510(k) abbreviated | PGY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262783) |
| July 22, 2026 | K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | Japan | Substantially Equivalent | 510(k) abbreviated | PSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260964) |
| July 15, 2026 | K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | Japan | Substantially Equivalent | 510(k) abbreviated | PSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253606) |
| July 10, 2026 | K253670 | SmartCT (R3.0 (L10)) | Philips Medical Systems B.V. | Netherlands | Substantially Equivalent | 510(k) abbreviated | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253670) |
| July 10, 2026 | K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | Spain | Substantially Equivalent | 510(k) abbreviated | PBX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253480) |
| July 8, 2026 | K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | Ohio | Substantially Equivalent | 510(k) abbreviated | EBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262300) |
| June 26, 2026 | K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | Washington | Substantially Equivalent | 510(k) abbreviated | GXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261442) |
| June 12, 2026 | K252996 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | North Carolina | Substantially Equivalent | 510(k) abbreviated | MQB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252996) |
| June 11, 2026 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | North Carolina | Substantially Equivalent | 510(k) abbreviated | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254145) |
| June 2, 2026 | K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | California | Substantially Equivalent | 510(k) abbreviated | EBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260569) |
| May 9, 2026 | K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | Delaware | Substantially Equivalent | 510(k) abbreviated | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261145) |
| May 4, 2026 | K252622 | Male Latex Condom HA | Okamoto USA, Inc. | Ohio | Substantially Equivalent | 510(k) abbreviated | HIS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252622) |
| April 28, 2026 | K253243 | Cardinal Health™ Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | Illinois | Substantially Equivalent | 510(k) abbreviated | FYA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253243) |
| April 14, 2026 | K260498 | TriMemo™ SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | Italy | Substantially Equivalent | 510(k) abbreviated | KRH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260498) |
| April 3, 2026 | K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | California | Substantially Equivalent | 510(k) abbreviated | GXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260363) |
| March 25, 2026 | K260274 | Airlock® Ankle Plating System | Novastep SAS | France | Substantially Equivalent | 510(k) abbreviated | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260274) |
| March 24, 2026 | K252099 | Trinias | Shimadzu Corporation | Japan | Substantially Equivalent | 510(k) abbreviated | OWB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252099) |
| March 23, 2026 | K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | Florida | Substantially Equivalent | 510(k) abbreviated | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254288) |
| March 12, 2026 | K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | Utah | Substantially Equivalent | 510(k) abbreviated | HGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252583) |
| February 23, 2026 | K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR... | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) abbreviated | LNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253648) |
| February 9, 2026 | K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | California | Substantially Equivalent | 510(k) abbreviated | GXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254033) |
| February 2, 2026 | K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) abbreviated | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252286) |
| January 23, 2026 | K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | Ohio | Substantially Equivalent | 510(k) abbreviated | MOS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253738) |
| December 23, 2025 | K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | California | Substantially Equivalent | 510(k) abbreviated | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250476) |
| December 19, 2025 | K254063 | iCEM Universal Plus | Kulzer, LLC | Indiana | Substantially Equivalent | 510(k) abbreviated | EMA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254063) |
| December 8, 2025 | K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | China | Substantially Equivalent | 510(k) abbreviated | EIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252789) |
| November 25, 2025 | K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | Singapore | Substantially Equivalent | 510(k) abbreviated | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252161) |
| November 18, 2025 | K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | Thailand | Substantially Equivalent | 510(k) abbreviated | HIS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252521) |
| November 6, 2025 | K252525 | AIO Breathe | Aiomega, LLC | Texas | Substantially Equivalent | 510(k) abbreviated | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252525) |
| October 31, 2025 | K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | California | Substantially Equivalent | 510(k) abbreviated | GXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251381) |
| October 31, 2025 | K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | New York | Substantially Equivalent | 510(k) abbreviated | FRG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250306) |
| October 24, 2025 | K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | Netherlands | Substantially Equivalent | 510(k) abbreviated | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252645) |
| October 17, 2025 | K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | Maryland | Substantially Equivalent | 510(k) abbreviated | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252075) |
| September 29, 2025 | K253236 | G-BLOCK | Graphenano Dental S.L. | Spain | Substantially Equivalent | 510(k) abbreviated | EBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253236) |
| September 23, 2025 | K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC | California | Substantially Equivalent | 510(k) abbreviated | KRH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251982) |
| September 17, 2025 | K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | California | Substantially Equivalent | 510(k) abbreviated | KRH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251688) |
| September 17, 2025 | K243752 | Double Tube Herbst Appliance | The Tmj Clinic PC | Oregon | Substantially Equivalent | 510(k) abbreviated | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243752) |
| September 2, 2025 | K242768 | Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) abbreviated | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242768) |
| August 28, 2025 | K252030 | RadiForce GX570; RadiForce GX570-AR | Eizo Corporation | Japan | Substantially Equivalent | 510(k) abbreviated | PGY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252030) |
| August 19, 2025 | K250313 | Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs... | Harps Europe Manufacturing GmbH | Austria | Substantially Equivalent | 510(k) abbreviated | KGO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250313) |
| August 18, 2025 | K243604 | Halyard Purple Nitrile-XTRA\* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with... | O&M Halyard, Inc. | Georgia | Substantially Equivalent | 510(k) abbreviated | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243604) |
| August 8, 2025 | K243254 | Parkell Pit and Fissure Sealant | Parkell, Inc. | New Jersey | Substantially Equivalent | 510(k) abbreviated | EBC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243254) |
| August 6, 2025 | K251854 | SteadiSet infusion set | Tandem Diabetes Care | California | Substantially Equivalent | 510(k) abbreviated | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251854) |
| August 4, 2025 | K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure... | Andon Health Co, Ltd. | China | Substantially Equivalent | 510(k) abbreviated | DXN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251113) |
| July 17, 2025 | K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) abbreviated | MOS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243428) |
| July 14, 2025 | K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | Acumed, LLC | Oregon | Substantially Equivalent | 510(k) abbreviated | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251132) |
| July 14, 2025 | K250504 | Leonardo Duster | Ceramoptec GmbH | Germany | Substantially Equivalent | 510(k) abbreviated | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250504) |
| July 11, 2025 | K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | Michigan | Substantially Equivalent | 510(k) abbreviated | KWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251436) |
| June 30, 2025 | K250670 | EchoConfidence (USA) | Mycardium AI Limited | United Kingdom | Substantially Equivalent | 510(k) abbreviated | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250670) |
| June 27, 2025 | K250969 | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST | Dent4you AG | Switzerland | Substantially Equivalent | 510(k) abbreviated | ELW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250969) |
| June 18, 2025 | K243172 | Halyard Purple Nitrile\* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile\* Powder-Free Exam... | O&M Halyard, Inc. | Virginia | Substantially Equivalent | 510(k) abbreviated | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243172) |
| June 5, 2025 | K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | Liechtenstein | Substantially Equivalent | 510(k) abbreviated | EIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251084) |
| May 30, 2025 | K243010 | Fluidshield \* 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield \* 3 Surgical... | Owens & Minor (O&M) Halyard, Inc. | Virginia | Substantially Equivalent | 510(k) abbreviated | FXX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243010) |
| May 28, 2025 | K240950 | Disposable Prophy Angle | Pacific Care Limited | Hong Kong | Substantially Equivalent | 510(k) abbreviated | EGS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240950) |
| May 23, 2025 | K242545 | RadiForce MX317W-PA | Eizo Corporation | Japan | Substantially Equivalent | 510(k) abbreviated | PZZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242545) |
| May 9, 2025 | K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | California | Substantially Equivalent | 510(k) abbreviated | FPA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242692) |
| April 24, 2025 | K242973 | CanMINI Hand and Foot System | Canwell Medical Co., Ltd. | China | Substantially Equivalent | 510(k) abbreviated | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242973) |
| April 21, 2025 | K243508 | Wearable breast pump (model S12A) | Shenzhen TPH Technology Co., Ltd. | China | Substantially Equivalent | 510(k) abbreviated | HGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243508) |
| April 11, 2025 | K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | Australia | Substantially Equivalent | 510(k) abbreviated | EBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243356) |
| February 21, 2025 | K242850 | Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. | China | Substantially Equivalent | 510(k) abbreviated | HGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242850) |
| February 18, 2025 | K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. | Ohio | Substantially Equivalent | 510(k) abbreviated | HIS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243584) |
| February 10, 2025 | K240958 | Locking Plates and Screws Systems | Hebei Ruihe Medical Devices Co., Ltd. | China | Substantially Equivalent | 510(k) abbreviated | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240958) |
| January 17, 2025 | K242064 | Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | North Carolina | Substantially Equivalent | 510(k) abbreviated | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242064) |
| January 8, 2025 | K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | Hiossen, Inc. | Pennsylvania | Substantially Equivalent | 510(k) abbreviated | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241003) |
| December 27, 2024 | K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | China | Substantially Equivalent | 510(k) abbreviated | ELW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241924) |
| December 19, 2024 | K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) abbreviated | IPF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240348) |
| December 17, 2024 | K242558 | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy... | O&M Halyard, Inc. | Virginia | Substantially Equivalent | 510(k) abbreviated | LZA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242558) |
| December 6, 2024 | K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | Spain | Substantially Equivalent | 510(k) abbreviated | PLF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240461) |
| December 4, 2024 | K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | China | Substantially Equivalent | 510(k) abbreviated | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242348) |
| November 27, 2024 | K243221 | RadiForce RX570; RadiForce RX570-AR | Eizo Corporation | Japan | Substantially Equivalent | 510(k) abbreviated | PGY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243221) |
| November 15, 2024 | K242062 | 1CMR Pro | Mycardium AI Limited | United Kingdom | Substantially Equivalent | 510(k) abbreviated | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242062) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Eizo Corporation | 4 | September 1, 2026 |
| Ceribell, Inc. | 3 | April 3, 2026 |
| O&M Halyard, Inc. | 3 | August 18, 2025 |
| Paragon Implant Mfg., LLC | 2 | September 17, 2026 |
| Hamamatsu Photonics K.K. | 2 | July 22, 2026 |
| Smart Denture Conversions, LLC | 2 | June 11, 2026 |
| Okamoto USA, Inc. | 2 | May 4, 2026 |
| Philips Medical Systems Nederland B.V. | 2 | February 23, 2026 |
| Chengdu Besmile Medical Technology Co., Ltd. | 2 | February 2, 2026 |
| Edwards Lifesciences, LLC | 2 | September 23, 2025 |
| Mycardium AI Limited | 2 | June 30, 2025 |
| Shenzhen TPH Technology Co., Ltd. | 2 | April 21, 2025 |
| Higia., Inc. d/b/a Eden | 1 | October 21, 2026 |
| True Function Laboratory, Inc. | 1 | October 6, 2026 |
| Ecomed Solutions, LLC | 1 | September 11, 2026 |
| Peerbridge Health, Inc. | 1 | September 4, 2026 |
| Philips Medical Systems B.V. | 1 | July 10, 2026 |
| Capenergy Medical S.L. | 1 | July 10, 2026 |
| Formlabs Ohio, Inc. | 1 | July 8, 2026 |
| Cadwell Industries, Inc. | 1 | June 26, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 22 | October 6, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 12 | October 21, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 9 | May 9, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 8 | September 11, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 6 | September 4, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 6 | May 4, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 5 | July 10, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 4 | June 26, 2026 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 3 | July 22, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 1 | December 19, 2024 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 11 | October 6, 2026 |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 10 | February 2, 2026 |
| [Japan](https://specstream.ai/data/fda-clearances/country/japan) | 7 | September 1, 2026 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 4 | July 8, 2026 |
| [Netherlands](https://specstream.ai/data/fda-clearances/country/netherlands) | 3 | July 10, 2026 |
| [Spain](https://specstream.ai/data/fda-clearances/country/spain) | 3 | July 10, 2026 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 3 | June 12, 2026 |
| [Virginia](https://specstream.ai/data/fda-clearances/state/virginia) | 3 | June 18, 2025 |
| [Delaware](https://specstream.ai/data/fda-clearances/state/delaware) | 2 | October 21, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 2 | September 11, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 2 | September 4, 2026 |
| [Singapore](https://specstream.ai/data/fda-clearances/country/singapore) | 2 | November 25, 2025 |
| [Oregon](https://specstream.ai/data/fda-clearances/state/oregon) | 2 | September 17, 2025 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 2 | July 17, 2025 |
| [United Kingdom](https://specstream.ai/data/fda-clearances/country/united-kingdom) | 2 | June 30, 2025 |
| [Washington](https://specstream.ai/data/fda-clearances/state/washington) | 1 | June 26, 2026 |
| [Italy](https://specstream.ai/data/fda-clearances/country/italy) | 1 | April 14, 2026 |
| [France](https://specstream.ai/data/fda-clearances/country/france) | 1 | March 25, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 1 | March 23, 2026 |
| [Utah](https://specstream.ai/data/fda-clearances/state/utah) | 1 | March 12, 2026 |
| [Indiana](https://specstream.ai/data/fda-clearances/state/indiana) | 1 | December 19, 2025 |
| Thailand | 1 | November 18, 2025 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 1 | November 6, 2025 |
| [Maryland](https://specstream.ai/data/fda-clearances/state/maryland) | 1 | October 17, 2025 |
| [Austria](https://specstream.ai/data/fda-clearances/country/austria) | 1 | August 19, 2025 |

## 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/).