# Pentax Medical, A Division of Pentax of America, Inc.

- Location (FDA's records): Redwood, Ca, CA
- FDA decisions: 2 (2019–2019): 2 510(k) clearances
- Product codes: OCX (1), GEH (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C2 Therapeutics, Inc.: 2 (https://510kreport.com/company/c2-therapeutics)

## Firms that cite its devices most
- Pentax of America, Inc.: 1 (https://510kreport.com/company/pentax-of-america)

## Its most-cited devices
- K190194: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (2019), cited by 1

## Recent decisions
- K193036: C2 CryoBalloon EndoGrip (Nov 22, 2019)
- K190194: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (May 31, 2019)

Source page: https://510kreport.com/company/pentax-medical-a-division-of-pentax-of-america