# NuMED, Inc.

- Location (FDA's records): Hopkinton, NY
- FDA decisions: 50 (1985–2022): 48 510(k) clearances, 1 De Novo grant and 1 original PMA approval
- Product codes: DQY (12), LIT (7), DQO (5), MJN (5), NVM (5), LDF (3), DXF (3), OMZ (2), DYB (2), OZT (2), PNF (1), DPT (1)
- 510(k) review time since 2016: median 110 days, against 70 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 35 (30 its own); citations of its devices by later devices: 48 (30 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W. L. Gore & Associates, Inc.: 2 (https://510kreport.com/company/w-l-gore-associates)
- Edwards Lifesciences, LLC: 2 (https://510kreport.com/company/edwards-lifesciences)
- Map Medical Equipment, Inc.: 1 (https://510kreport.com/company/map-medical-equipment)

## Firms that cite its devices most
- Intervalve, Inc.: 4 (https://510kreport.com/company/intervalve)
- Ekos Corp.: 3 (https://510kreport.com/company/ekos)
- Edwards Lifesciences, LLC: 3 (https://510kreport.com/company/edwards-lifesciences)
- Toray Industries, Inc.: 1 (https://510kreport.com/company/toray-industries)
- Aga Medical Corp.: 1 (https://510kreport.com/company/aga-medical)
- Pfm Medical, Inc.: 1 (https://510kreport.com/company/pfm-medical)
- Trireme Medical, Inc.: 1 (https://510kreport.com/company/trireme-medical)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Its most-cited devices
- K931009: Tyshak Peripheral Balloon Dilation Catheter (1993), cited by 4
- DEN080015: Nucleus-X PTV Catheter (2012), cited by 4
- K122012: Z-Med Z-Med II (2012), cited by 4
- K022722: Pta and PTV (2002), cited by 3
- K003972: Numed Ghost II Pta Catheters (2001), cited by 3
- K003276: Tyshak Mini Pediatric PTV Catheter, Model 107 (2000), cited by 2

## Recent decisions
- K213915: BIB Stent Placement Catheter (Jan 12, 2022)
- K211910: Z-6 Atrioseptostomy Catheter (Jul 19, 2021)
- K211134: BIB Stent Placement Catheter (May 27, 2021)
- K190974: D'Vill Introducer (May 14, 2019)
- K171206: D'Vill Introducer (Oct 20, 2017)
- K161451: BIB Stent Placement Catheter (Sep 22, 2016)
- K160598: REBOA Balloon Catheter (Jun 20, 2016)
- K160889: BIB Stent Placement Catheter (May 20, 2016)

Source page: https://510kreport.com/company/numed