# Cardiomedics, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 5 (1987–2005): 5 510(k) clearances
- Product codes: DRN (5)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vasomedical, Inc.: 2 (https://510kreport.com/company/vasomedical)
- Nicore Equipment & Leasing, Inc.: 1 (https://510kreport.com/company/nicore-equipment-leasing)

## Firms that cite its devices most
- Circulator Boot Corp.: 1 (https://510kreport.com/company/circulator-boot)

## Its most-cited devices
- K022107: Cardiassist Counterpulsation System, Model Mark 3000 (2002), cited by 2
- K010261: Cardiomedics Ecp System (2001), cited by 1
- K023427: Cardiassist Counterpulsation System, Model Mark 3000 (2003), cited by 1

## Recent decisions
- K050172: Cardiassist Counter Pulsation System Series 4000/5000 (Mar 31, 2005)
- K023427: Cardiassist Counterpulsation System, Model Mark 3000 (Jan 7, 2003)
- K022107: Cardiassist Counterpulsation System, Model Mark 3000 (Aug 8, 2002)
- K010261: Cardiomedics Ecp System (Feb 28, 2001)
- K872034: Cardiomedics External Counterpulsation System (Sep 18, 1987)

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