# K173483: Pure Flow External Counter-Pulsation Device

- Pathway: 510(k) (Traditional)
- Applicant: Xtreem Pulse, LLC
- Decided: May 30, 2018 after 198 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: 3 generations back to K980937 (2000). 4 ancestors in all.
2 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)
- K152115: Renew NCP-5 External Counterpulsation System, Stage 2 Innovations (2015) Summary page 4.

## Most influential descendants
- K190683: External Counterpulsation System (2019), 1 descendant of its own
- K202108: External Counterpulsation System, Soulaire (2020), 0 descendants of its own

## Indications for use
The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

Source page: https://510kreport.com/device/K173483
Methodology: https://510kreport.com/methodology