# K022107: Cardiassist Counterpulsation System, Model Mark 3000

- Pathway: 510(k) (Traditional)
- Applicant: Cardiomedics, Inc.
- Decided: Aug 8, 2002 after 41 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
Longest line of descent: 2 generations back to K940264 (1995). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010261: Cardiomedics Ecp System, Cardiomedics, Inc. (2001)
- K020857: Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter, Vasomedical, Inc. (2002)

## Most influential descendants
- 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

## Indications for use
The CardioMedics, Inc., CardiAssist CounterPulsation System is intended to provide external counterpulsation (ECP) for the treatment of ischemic heart disease by increasing perfusion during diastole in people with chronic angina pectoris, congestive heart failure, myocardial infarction and cardiogenic shock. Use of this device may reduce pain and impairment associated with angina pectoris, congestive heart failure or myocardial infarction and may enhance coronary function.

Source page: https://510kreport.com/device/K022107
Methodology: https://510kreport.com/methodology