# K012141: Aecp-a, Automatic External Counterpulsation Device

- Pathway: 510(k) (Traditional)
- Applicant: External Counterpulsation Lab
- Decided: Oct 25, 2001 after 107 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023701: Angionew-IV (2003), 1 descendant of its own
- K033657: Mobile External Counter Pulsation System Angionew-V (2003), 0 descendants of its own

## Indications for use
The AECP-A is a non-invasive external couterpulsation device for treatment of patients suffering from stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock

Source page: https://510kreport.com/device/K012141
Methodology: https://510kreport.com/methodology