# K980937: Nicore Model Esp -1

- Pathway: 510(k) (Traditional)
- Applicant: Nicore Equipment & Leasing, Inc.
- Decided: Sep 15, 2000 after 918 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
Stable Angine Pectoris

Source page: https://510kreport.com/device/K980937
Methodology: https://510kreport.com/methodology