# K023016: Nicore Model NCP-1 External Counterpulsation Device

- Pathway: 510(k) (Traditional)
- Applicant: Nicore Equipment & Leasing, Inc.
- Decided: Dec 4, 2002 after 85 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vasomedical Model EECP-MC2: named in the summary without a submission number

## Most influential descendants
- K042413: Acs Model NCP-2 (2004), 5 descendants of its own
- 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

## Indications for use
The NICORE Model NCP-I is used to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

Source page: https://510kreport.com/device/K023016
Methodology: https://510kreport.com/methodology