# K200285: VenaOne

- Pathway: 510(k) (Traditional)
- Applicant: Vena Group, LLC
- Decided: Jul 2, 2020 after 148 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: 5 generations back to K915638 (1992). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130174: Dvtcare CA5, Ossur Americas, Inc. (2013) Summary page 4.
- K161209: Cirona 6400, Devon Medical Products (2016) Summary page 4.

## Most influential descendants
- K212731: Circul8 Pro (2021), 0 descendants of its own

## Indications for use
VenaOne is an easy to use system prescribed by healthcare professionals for stimulating blood flow in the legs (simulating muscle contractions) that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.

Source page: https://510kreport.com/device/K200285
Methodology: https://510kreport.com/methodology