# K010261: Cardiomedics Ecp System

- Pathway: 510(k) (Special)
- Applicant: Cardiomedics, Inc.
- Decided: Feb 28, 2001 after 30 days
- Product code: DRN (Device, Counter-Pulsating, External)
- Device class: 2
- Regulation: 21 CFR 870.5225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K022107: Cardiassist Counterpulsation System, Model Mark 3000 (2002), 3 descendants of its own
- K023427: Cardiassist Counterpulsation System, Model Mark 3000 (2003), 1 descendant of its own
- K082134: Circulator Boot (2009), 0 descendants of its own
- K050172: Cardiassist Counter Pulsation System Series 4000/5000 (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K010261
Methodology: https://510kreport.com/methodology