# K250756: Pression Wave PRO External Counter-Pulsation System

- Pathway: 510(k) (Traditional)
- Applicant: Pression, Inc.
- Decided: Dec 22, 2025 after 285 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: 2 generations back to K980937 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042413: Acs Model NCP-2, Applied Cardiac Systems (2004) Summary page 5.

## Indications for use
The Pression Wave PRO External Counter-Pulsation System is indicated for the treatment of chronic stable angina (CSA) that is refractory to optimal anti-anginal medical therapy and without options for revascularization in adult patients that weigh greater than 40kg. In addition, it is intended for use in healthy adult patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the supervision of a healthcare professional.

Source page: https://510kreport.com/device/K250756
Methodology: https://510kreport.com/methodology