# Cryogen, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 4 (1997–2000): 4 510(k) clearances
- Product codes: GEH (2), OCL (1), GEI (1)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 6 (2 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
- Frigitronics of Connecticut, Inc.: 2 (https://510kreport.com/company/frigitronics-of-connecticut)
- Cryomedical Sciences, Inc.: 2 (https://510kreport.com/company/cryomedical-sciences)
- Spembly Medical, Ltd.: 1 (https://510kreport.com/company/spembly-medical)
- Heartport, Inc.: 1 (https://510kreport.com/company/heartport)

## Firms that cite its devices most
- AtriCure, Inc.: 2 (https://510kreport.com/company/atricure)
- Afx, Inc.: 1 (https://510kreport.com/company/afx)
- Guidant Corporation, Cardiac Surgery: 1 (https://510kreport.com/company/guidant-cardiac-surgery)

## Its most-cited devices
- K974320: Cryogen Cardiac Cryosurgical System (1998), cited by 3
- K972662: Cryogen Cryosurgical System (1997), cited by 1
- K003050: Cryosurgical Unit and Accessories (2000), cited by 1
- K964971: Cryogen Cryosurgical System (1997), cited by 1

## Recent decisions
- K003050: Cryosurgical Unit and Accessories (Dec 26, 2000)
- K974320: Cryogen Cardiac Cryosurgical System (Feb 3, 1998)
- K972662: Cryogen Cryosurgical System (Oct 1, 1997)
- K964971: Cryogen Cryosurgical System (Mar 28, 1997)

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