# K202108: External Counterpulsation System, Soulaire

- Pathway: 510(k) (Special)
- Applicant: Vamed Medical Instrument Co., Ltd.
- Decided: Aug 28, 2020 after 29 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: 5 generations back to K980937 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190683: External Counterpulsation System, Vamed Medical Instrument Co., Ltd. (2019) Summary page 4.

## Indications for use
The External Counterpulsation System, Soulaire 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, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

Source page: https://510kreport.com/device/K202108
Methodology: https://510kreport.com/methodology