# K012597: Sterilmed Reprocessed Compression Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Feb 11, 2002 after 185 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 K781357 (1978). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781357: T.E.D. Sequential Compression Sleeves, Kendall Research Center (1978) Summary page 1.
- K953648: A-V Impulse System Model 6060, Novamedix, Ltd. (1996) Summary page 1.
- K951683: A-V Impulse System Model 6060, Novamedix, Ltd. (1995) Summary page 1.
- K910188: Flowplus AC330 Pump Garments, Huntleigh Technology, Inc. (1991) Summary page 1.

## Most influential descendants
- K052691: Suretek Medical Reprocessed Compression Sleeves (2006), 0 descendants of its own

## Indications for use
These devices are reprocessed compression sleeves from various original equipment manufacturers (OEM.) Compression sleeves are designed to provide external intermittent or sequential limb compression to artificially imitate the pumping action of the lower limbs to: prevent deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.

Source page: https://510kreport.com/device/K012597
Methodology: https://510kreport.com/methodology