# K190976: Radial Medical Compression System

- Pathway: 510(k) (Special)
- Applicant: Radial Medical, Inc.
- Decided: Jul 12, 2019 after 88 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944567 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181651: Radial Medical Compression System, Radial Medical, Inc. (2018) Summary page 4.

## Indications for use
The Radial Medical Cirvo Compression System is indicated for use in: * Preventing deep vein thrombosis (DVT) * Enhancing blood circulation * Diminishing post-operative pain and swelling * Reducing wound healing time * Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers * Treatment of chronic venous insufficiency * Reducing edema

Source page: https://510kreport.com/device/K190976
Methodology: https://510kreport.com/methodology