# FDA device clearances in New York: 159 since Nov 2024

Updated October 30, 2026.

FDA made 159 device decisions for applicants in New York from November 15, 2024 to October 30, 2026: 107 510(k) clearances and De Novo grants and 52 PMA approvals and supplements, for 78 applicants. The newest, K263076 on October 30, 2026, is AngioVac F1885 from AngioDynamics, Inc..

## The full list

FDA device clearances for applicants in New York: 159 rows for $7.95, 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 10 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 5 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/state/new-york

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: 159
- 510(k) and De Novo: 107
- PMA: 52
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 159, 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 | K263076 | AngioVac F1885 | AngioDynamics, Inc. | New York | Substantially Equivalent | 510(k) traditional | DWF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263076) |
| October 27, 2026 | K261714 | FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors | Transonic Systems, Inc. | New York | Substantially Equivalent | 510(k) traditional | DPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261714) |
| October 26, 2026 | K261997 | NeuroAlign | Medivis, Inc. | New York | Substantially Equivalent | 510(k) traditional | HAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261997) |
| October 23, 2026 | P240005/S010 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S010) |
| October 16, 2026 | K262941 | Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens | Bausch + Lomb, Inc. | New York | Substantially Equivalent | 510(k) traditional | LPL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262941) |
| October 14, 2026 | P240005/S009 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S009) |
| October 7, 2026 | K260075 | eClinics | Ceiba Healthcare US, Inc. | New York | Substantially Equivalent | 510(k) traditional | MSX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260075) |
| September 30, 2026 | P240005/S008 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S008) |
| September 22, 2026 | P010007/S028 | IMMULITE Systems AFP | Siemens Healthcare Diagnostics, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S028) |
| September 14, 2026 | P170035/S021 | Bausch + Lomb Ultra (samfilcon A) Contact Lenses | Bausch and Lomb, Inc., | New York | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170035S021) |
| September 11, 2026 | K262861 | PureLift Pro Max | Xtreem Pulse, LLC | New York | Substantially Equivalent | 510(k) special | NFO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262861) |
| September 11, 2026 | K261580 | ZBPro Diagnostic (Version 2.0) | Zbeats, Inc. | New York | Substantially Equivalent | 510(k) traditional | MLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261580) |
| September 11, 2026 | K261305 | MICSI-PET | Microstructure Imaging, Inc. | New York | Substantially Equivalent | 510(k) traditional | KPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261305) |
| 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 3, 2026 | P240005/S007 | enVista Envy™ hydrophobic acrylic intraocular lens (IOL) | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S007) |
| September 3, 2026 | DEN250044 | Queen of Hearts (ACS AI ECG Model) | Powerful Medical, Inc. | New York | Unknown | De Novo | SHS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250044) |
| August 31, 2026 | K261718 | EZFluence (RADEZ V2) | Radformation, Inc. | New York | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261718) |
| August 27, 2026 | K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System... | Ascensia Diabetes Care | New York | Substantially Equivalent | 510(k) traditional | NBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260545) |
| August 26, 2026 | P240021/S001 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA 180-day supplement | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240021S001) |
| August 20, 2026 | P010007/S027 | IMMULITE Systems AFP | Siemens Healthcare Diagnostics, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S027) |
| August 14, 2026 | K262452 | AutoContour (RADAC V6) | Radformation, Inc. | New York | Substantially Equivalent | 510(k) special | QKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262452) |
| August 12, 2026 | P240005/S005 | enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular... | Bausch & Lomb, Inc. | New York | Approved | PMA special supplement | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S005) |
| 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 10, 2026 | K253528 | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | NIG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253528) |
| July 30, 2026 | K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | New York | Substantially Equivalent | 510(k) traditional | LFL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261448) |
| July 30, 2026 | K254038 | Motivista (CT-155) | Click Therapeutics, Inc. | New York | Substantially Equivalent | 510(k) traditional | SAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254038) |
| July 29, 2026 | K251908 | Emanate Tray | Emanate Biomedical | New York | Substantially Equivalent | 510(k) traditional | OLR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251908) |
| July 27, 2026 | P010007/S026 | IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S026) |
| July 24, 2026 | K261364 | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | LDP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261364) |
| July 22, 2026 | P240005/S006 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S006) |
| July 17, 2026 | K251952 | Virasight | Virasoft Corporation | New York | Substantially Equivalent | 510(k) traditional | PSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251952) |
| July 10, 2026 | K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | New York | Substantially Equivalent | 510(k) special | FYA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261949) |
| July 6, 2026 | P150028/S007 | CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP... | NuMED, Inc. | New York | Approved | PMA 180-day supplement | PNF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150028S007) |
| July 2, 2026 | K253884 | Koios DS (3.8) | Koios Medical, Inc. | New York | Substantially Equivalent | 510(k) traditional | POK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253884) |
| July 2, 2026 | K253704 | iPredict-DR | iHealthscreen, Inc. | New York | Substantially Equivalent | 510(k) traditional | PIB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253704) |
| July 1, 2026 | K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | New York | Substantially Equivalent | 510(k) traditional | EBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261485) |
| June 30, 2026 | K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | New York | Substantially Equivalent | 510(k) traditional | EIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262195) |
| June 26, 2026 | K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | New York | Substantially Equivalent | 510(k) traditional | DQO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261455) |
| June 22, 2026 | K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | New York | Substantially Equivalent | 510(k) traditional | NUC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254011) |
| June 17, 2026 | K260006 | INOSS System | Inosys, Inc. | New York | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260006) |
| June 16, 2026 | P910018/S042 | LIPOSORBER® LA-15 System | Kaneka Pharma America Corp. | New York | 30-day notice accepted | PMA 30-day notice | MMY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910018S042) |
| June 8, 2026 | K260332 | EchoNext | Pathwai, Inc. | New York | Substantially Equivalent | 510(k) traditional | QXO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260332) |
| June 4, 2026 | K252575 | Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | New York Embroidery Studio (NYES) | New York | Substantially Equivalent | 510(k) traditional | FYA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252575) |
| May 29, 2026 | K252840 | M12 Telemetry System | Global Instrumentation, LLC | New York | Substantially Equivalent | 510(k) traditional | MHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252840) |
| 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 21, 2026 | K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | New York | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251920) |
| May 13, 2026 | K261363 | Y-Knotless™ Flex Anchors | CONMED Corporation | New York | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261363) |
| May 11, 2026 | P250026 | Atellica IM free PSA II (fPSAII) | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA original approval | MTG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250026) |
| May 5, 2026 | K261132 | Healium Intelliscan LX192LC | Healium Intelliscan Corporation | New York | Substantially Equivalent | 510(k) special | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261132) |
| 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 30, 2026 | DEN250023 | Aurie System | Cathbuddy, Inc. | New York | Unknown | De Novo | SHV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250023) |
| April 27, 2026 | K252628 | CASSIE | Wesper, Inc. | New York | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252628) |
| April 22, 2026 | K253765 | VANISH PRO | Ddc Technologies, Inc. | New York | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253765) |
| April 21, 2026 | P010007/S025 | IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA 180-day supplement | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S025) |
| April 7, 2026 | K253905 | PrimeSight UltraView System | Cogentix Medical, Inc. | New York | Substantially Equivalent | 510(k) traditional | FAJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253905) |
| April 3, 2026 | K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | New York | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253962) |
| March 30, 2026 | P910018/S041 | LIPOSORBER® LA-15 System | Kaneka Pharma America Corp. | New York | Approved | PMA real-time process supplement | MMY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910018S041) |
| March 25, 2026 | K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | New York | Substantially Equivalent | 510(k) special | DQO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254278) |
| March 19, 2026 | K260509 | AutoContour (RADAC V5) | Radformation, Inc. | New York | Substantially Equivalent | 510(k) special | QKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260509) |
| March 13, 2026 | P200044/S013 | LungFit PH | Beyond Air, Inc. | New York | 30-day notice accepted | PMA 30-day notice | QTB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200044S013) |
| March 12, 2026 | K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | New York | Substantially Equivalent | 510(k) traditional | OMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253429) |
| March 11, 2026 | K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health | New York | Substantially Equivalent | 510(k) traditional | IZL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253185) |
| March 10, 2026 | K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | New York | Substantially Equivalent | 510(k) traditional | EIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253953) |
| March 6, 2026 | K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | New York | Substantially Equivalent | 510(k) traditional | HIB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252208) |
| March 5, 2026 | K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | New York | Substantially Equivalent | 510(k) traditional | KLE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252450) |
| March 4, 2026 | DEN250012 | LifeVac | Lifevac, LLC | New York | Unknown | De Novo | QXN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250012) |
| February 13, 2026 | K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | New York | Substantially Equivalent | 510(k) traditional | DXG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253092) |
| February 10, 2026 | K251515 | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | New York | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251515) |
| February 6, 2026 | K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | JLW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251543) |
| January 29, 2026 | K253763 | Y-Knotless™ Flex Anchors | Conmed Corporation | New York | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253763) |
| January 27, 2026 | K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | New York | Substantially Equivalent | 510(k) special | GEI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254220) |
| January 20, 2026 | K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health | New York | Substantially Equivalent | 510(k) traditional | KPR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250954) |
| January 5, 2026 | K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | New York | Substantially Equivalent | 510(k) traditional | IYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252988) |
| January 5, 2026 | K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | LTJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251630) |
| December 23, 2025 | K252187 | Aura Glide (FC40) | Aura Medical, LLC | New York | Substantially Equivalent | 510(k) traditional | NFO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252187) |
| December 22, 2025 | K252361 | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | New York | Substantially Equivalent | 510(k) traditional | DPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252361) |
| December 19, 2025 | P200007/S002 | HeartSync Multifunction Disposable Single-Use Defibrillator Pads | Graphic Controls D.B.A. Vermed | New York | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200007S002) |
| December 19, 2025 | K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | New York | Substantially Equivalent | 510(k) traditional | MUJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252863) |
| December 17, 2025 | K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | New York | Substantially Equivalent | 510(k) traditional | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252518) |
| December 16, 2025 | P860022/S061 | Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A) | Bausch & Lomb | New York | 30-day notice accepted | PMA 30-day notice | MWL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860022S061) |
| December 16, 2025 | P010062/S015 | Boston Orthokeratology (oprifocon A) | Bausch & Lomb | New York | 30-day notice accepted | PMA 30-day notice | NUU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010062S015) |
| December 16, 2025 | K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and... | Spectrum Vascular | New York | Substantially Equivalent | 510(k) traditional | LJS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252373) |
| December 12, 2025 | K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | New York | Substantially Equivalent | 510(k) special | QSY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253609) |
| December 5, 2025 | K253868 | QuietLab Pro | QuietLab, LLC | New York | Substantially Equivalent | 510(k) traditional | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253868) |
| December 4, 2025 | P170035/S019 | Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses | Bausch and Lomb, Inc., | New York | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170035S019) |
| December 3, 2025 | P240021 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA original approval | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240021) |
| November 24, 2025 | K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. | New York | Substantially Equivalent | 510(k) traditional | QEZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252509) |
| November 12, 2025 | P200007/S001 | HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads | Graphic Controls D.B.A. Vermed | New York | Approved | PMA 135-day supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200007S001) |
| 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 30, 2025 | P010007/S024 | IMMULITE 2000 AFP | Siemens Healthcare Diagnostics, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LOK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010007S024) |
| October 29, 2025 | K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | New York | Substantially Equivalent | 510(k) special | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253355) |
| October 29, 2025 | K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | New York | Substantially Equivalent | 510(k) traditional | MMI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252393) |
| October 24, 2025 | N16895/S107 | Bausch & Lomb SofLens® (polymacon) Contact Lenses | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=N16895S107) |
| October 24, 2025 | K253106 | AngioVac Cannula | AngioDynamics, Inc. | New York | Substantially Equivalent | 510(k) special | DWF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253106) |
| October 22, 2025 | K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | New York | Substantially Equivalent | 510(k) traditional | LRK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251628) |
| October 21, 2025 | K231897 | NeuroAlign software | Medivis, Inc. | New York | Substantially Equivalent | 510(k) traditional | HAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231897) |
| October 17, 2025 | P210019/S004 | Atellica IM HBc Total 2 (HBcT2) | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA real-time process supplement | LOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210019S004) |
| October 17, 2025 | P200017/S005 | Atellica IM Anti-HBe2 (aHBe2) | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA real-time process supplement | LOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200017S005) |
| October 17, 2025 | P110041/S017 | Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory | Siemens Corp. | New York | Approved | PMA real-time process supplement | LOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110041S017) |
| October 17, 2025 | P110041/S016 | Atellica IM Hepatitis B surface Antigen II (HBsII) | Siemens Corp. | New York | Approved | PMA 180-day supplement | LOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110041S016) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Siemens Healthcare Diagnostics, Inc. | 21 | September 22, 2026 |
| Bausch & Lomb, Inc. | 14 | October 23, 2026 |
| Radformation, Inc. | 7 | August 31, 2026 |
| Spectrum Vascular | 6 | August 10, 2026 |
| Conmed Corporation | 6 | January 29, 2026 |
| Kaneka Pharma America Corp. | 5 | June 16, 2026 |
| Beyond Air, Inc. | 4 | March 13, 2026 |
| Siemens Corp. | 4 | October 17, 2025 |
| AngioDynamics, Inc. | 3 | October 30, 2026 |
| Bausch and Lomb, Inc., | 3 | September 14, 2026 |
| Ivoclar Vivadent, Inc. | 3 | July 1, 2026 |
| Genadyne Biotechnologies, Inc. | 3 | March 12, 2026 |
| Bausch & Lomb | 3 | December 16, 2025 |
| Medivis, Inc. | 2 | October 26, 2026 |
| Xtreem Pulse, LLC | 2 | September 11, 2026 |
| Zbeats, Inc. | 2 | September 11, 2026 |
| Click Therapeutics, Inc. | 2 | July 30, 2026 |
| Koios Medical, Inc. | 2 | July 2, 2026 |
| Dcstar, Inc. | 2 | May 21, 2026 |
| Carestream Health | 2 | March 11, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 24 | October 23, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 19 | September 11, 2026 |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 18 | October 30, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 13 | September 22, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 11 | October 17, 2025 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 10 | July 10, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 10 | July 1, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 9 | August 10, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 8 | October 26, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 8 | June 16, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 7 | May 21, 2026 |
| Unknown | 6 | September 3, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 6 | May 13, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 4 | August 27, 2026 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 2 | July 17, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 2 | June 22, 2026 |
| [Clinical Toxicology](https://specstream.ai/data/fda-clearances/panel/clinical-toxicology) | 1 | July 24, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 1 | March 4, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 84 | October 30, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 23 | October 23, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 17 | September 11, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 13 | August 26, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 11 | March 30, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 4 | September 3, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 2 | September 4, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 2 | May 11, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 2 | November 12, 2025 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 1 | August 12, 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/).