# K122609: Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model FLS-0002; Vasculaire Sleeve (Calf) F

- Pathway: 510(k) (Traditional)
- Applicant: Venous Health Systems, Inc.
- Decided: Dec 21, 2012 after 116 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 K944567 (1995). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103113: Vasculaire Compression System, Venous Health Systems, Inc. (2011) Summary page 2.
- K012994: Wizair DVT, Medical Compression Systems (Dbn), Ltd. (2002) Summary page 2.
- K060146: Activecare ++ System, Medical Compression Systems (Dbn), Ltd. (2006) Summary page 2.
- K944567: Cowboy X, Kinetic Concepts, Inc. (1995) Summary page 2.
- K981311: Cowboy XV, Kci New Technologies, Inc. (1999) Summary page 2.

## Most influential descendants
- K181651: Radial Medical Compression System (2018), 1 descendant of its own
- K190976: Radial Medical Compression System (2019), 0 descendants of its own
- K131046: Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf) (2013), 0 descendants of its own

## Indications for use
The Vasculaire 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/K122609
Methodology: https://510kreport.com/methodology