# K981311: Cowboy XV

- Pathway: 510(k) (Traditional)
- Applicant: Kci New Technologies, Inc.
- Decided: Apr 23, 1999 after 378 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: 1 generation back to K944567 (1995). 1 ancestor in all.
88 later devices descend from it; 8 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944567: Cowboy X, Kinetic Concepts, Inc. (1995) Summary page 2.

## Most influential descendants
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps (2006), 52 descendants of its own
- K993758: Proair 3000 Compression System (2000), 31 descendants of its own
- K060146: Activecare ++ System (2006), 30 descendants of its own
- K103187: Tripleplay-VT Vascular Therapy System (2011), 25 descendants of its own
- K133274: Vena Pro (2014), 22 descendants of its own

## Indications for use
The Cowboy XV is designed to enhance blood circulation in the venules and arterioles in patients with diabetic ulcers of the lower extremities. Cowboy XV is intended for patient’s in the home who would benefit from increased blood flow to: treat and assist healing of cutaneous ulceration (wounds). reduce wound healing time. enhance arterial circulation (blood flow). prevent venous stasis (slowing of blood flow). reduce compartmental pressures. reduce edema (swelling). reduce post-operative pain and swelling. reduce the need for anticoagulant medications (medications that thin the blood). prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins).

Source page: https://510kreport.com/device/K981311
Methodology: https://510kreport.com/methodology