# Osypka Medical, Inc.

- Location (FDA's records): La Jolla, CA
- FDA decisions: 7 (2002–2013): 7 510(k) clearances
- Product codes: DTE (4), DSB (3)
- Predicates its devices cite: 16 (5 its own); citations of its devices by later devices: 7 (5 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
- Sulzer Oscor, Inc.: 3 (https://510kreport.com/company/sulzer-oscor)
- Oscor Medical Corp.: 3 (https://510kreport.com/company/oscor-medical)
- Medtronic Vascular: 2 (https://510kreport.com/company/medtronic-vascular)
- Cardiodynamics International Corp.: 1 (https://510kreport.com/company/cardiodynamics-international)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- Biotronik, Inc.: 1 (https://510kreport.com/company/biotronik)

## Firms that cite its devices most
- Sensible Medical Innovations, Ltd.: 2 (https://510kreport.com/company/sensible-medical-innovations)

## Its most-cited devices
- K070985: Aesculon CHF, Hypertension & Pacemaker Clinic (2008), cited by 2
- K081035: Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2 (2008), cited by 2
- K020896: Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene (2002), cited by 2
- K022939: Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and Accessories (2002), cited by 1

## Recent decisions
- K123916: Psa Series (Apr 9, 2013)
- K082242: Icon, Model C3 (Oct 8, 2008)
- K081035: Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2 (May 30, 2008)
- K070985: Aesculon CHF, Hypertension & Pacemaker Clinic (Feb 1, 2008)
- K033130: Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator (Oct 31, 2003)
- K022939: Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and Accessories (Oct 3, 2002)
- K020896: Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene (Jun 14, 2002)

Source page: https://510kreport.com/company/osypka-medical