# K944567: Cowboy X

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Jun 21, 1995 after 275 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
91 later devices descend from it; 7 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981311: Cowboy XV (1999), 88 descendants of its own
- 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

## Recalls of this device
- Nov 4, 2009 · Not classified · Z-0663-2010: Power cords may crack and fail inside plug with potential for fire hazard.

Source page: https://510kreport.com/device/K944567
Methodology: https://510kreport.com/methodology