# K131046: Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)

- Pathway: 510(k) (Traditional)
- Applicant: Venous Health Systems, Inc.
- Decided: Jul 18, 2013 after 94 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: 6 generations back to K944567 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122609: Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model FLS-0002; Vasculaire Sleeve (Calf) F, Venous Health Systems, Inc. (2012) Summary page 2.
- K120944: Kendall SCD 700 Sequential Compression Controller, Covidien (2012) Summary page 2.

## Indications for use
The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide sequential compression therapy to the lower limb(s) in the clinical setting or home environment. 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/K131046
Methodology: https://510kreport.com/methodology