# K100909: Reprocessed Compression Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: Jul 23, 2010 after 113 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
Longest line of descent: 4 generations back to K881632 (1988). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060049: Reprocessed Compression Sleeves, Alliance Medical Corp. (2006) Summary page 1.
- K060091: Alliance Medical Corporation Reprocessed Compression Sleeves, Alliance Medical Corp. (2006) Summary page 1.
- K053316: Reprocessed Compression Sleeves, Alliance Medical Corp. (2006) Summary page 1.
- K051438: Vanguard Reprocessed Compression Garments (Hill-Rom), Alliance Medical, Inc. (2006) Summary page 1.
- K012403: Vanguard Reprocessed Compression Garment, Vanguard Medical Concepts, Inc. (2001) Summary page 1.
- K024087: Reprocessed Compression Sleeves, Alliance Medical Corp. (2003) Summary page 1.
- K024074: Reprocessed Compression Sleeves, Alliance Medical Corp. (2003) Summary page 1.
- K021654: Reprocessed Compression Sleeve, Alliance Medical, Inc. (2003) Summary page 1.
- K011192: Compressible Limb Sleeve, Alliance Medical Corp. (2001) Summary page 1.

## Recalls of this device
- Apr 14, 2023 · Class II · Z-1612-2023: Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

## Indications for use
When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

Source page: https://510kreport.com/device/K100909
Methodology: https://510kreport.com/methodology