# K101087: Reprocessed Restep Compression Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Heatlhcare Solutions
- Decided: Jul 16, 2010 after 88 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: 2 generations back to K991038 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090308: Restep Dvy System, Model RSP-101, Stortford Medical, LLC (2009) Summary page 1.

## Indications for use
Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.

Source page: https://510kreport.com/device/K101087
Methodology: https://510kreport.com/methodology