# K042413: Acs Model NCP-2

- Pathway: 510(k) (Traditional)
- Applicant: Applied Cardiac Systems
- Decided: Dec 9, 2004 after 93 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: 1 generation back to K980937 (2000). 2 ancestors in all.
5 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)
- K980937: Nicore Model Esp -1, Nicore Equipment & Leasing, Inc. (2000) Summary page 1.
- K023016: Nicore Model NCP-1 External Counterpulsation Device, Nicore Equipment & Leasing, Inc. (2002) Summary page 1.

## Most influential descendants
- K152115: Renew NCP-5 External Counterpulsation System (2015), 3 descendants of its own
- K173483: Pure Flow External Counter-Pulsation Device (2018), 2 descendants of its own
- K190683: External Counterpulsation System (2019), 1 descendant of its own
- K250756: Pression Wave PRO External Counter-Pulsation System (2025), 0 descendants of its own
- K202108: External Counterpulsation System, Soulaire (2020), 0 descendants of its own

## Indications for use
Current indications for use of the ACSTM Model NCP-2 are: Stable Angina Pectoris Unstable Angina Pectoris Acute Myocardial Infarction Cardiogenic Shock Congestive Heart Failure

Source page: https://510kreport.com/device/K042413
Methodology: https://510kreport.com/methodology