# K012979: Compressible Limb Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Services, Inc.
- Decided: May 8, 2002 after 245 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 K942664 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942664: Kendall Model 6325 SCD Sequel Compression System, The Kendal Co. (1995) Summary page 1.

## Indications for use
The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.

Source page: https://510kreport.com/device/K012979
Methodology: https://510kreport.com/methodology