# K050172: Cardiassist Counter Pulsation System Series 4000/5000

- Pathway: 510(k) (Traditional)
- Applicant: Cardiomedics, Inc.
- Decided: Mar 31, 2005 after 64 days
- Product code: DRN (Device, Counter-Pulsating, External)
- Device class: 2
- Regulation: 21 CFR 870.5225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940264 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023427: Cardiassist Counterpulsation System, Model Mark 3000, Cardiomedics, Inc. (2003) Summary page 1.
- K023016: Nicore Model NCP-1 External Counterpulsation Device, Nicore Equipment & Leasing, Inc. (2002) Summary page 1.

## Recalls of this device
- Apr 9, 2009 · Not classified · Z-1582-2009: Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape o

## Indications for use
The Cardiomedics, Inc., CardiAssist Counter Pulsation System - Series 4000 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/K050172
Methodology: https://510kreport.com/methodology