# K052691: Suretek Medical Reprocessed Compression Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Suretek Medical
- Decided: May 17, 2006 after 231 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: 3 generations back to K881632 (1988). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022786: DVT60, Huntleigh Healthcare, Inc. (2002) Summary page 1.
- K010744: Flowtron Universal, Model AC600, Huntleigh Healthcare, Inc. (2002) Summary page 1.
- K992079: Kendall Model 7325 SCD Response Compression System, Model 7325, The Kendall Company, L.P. (1999) Summary page 1.
- K964425: A-V Impulse System Model 6060, Powell,Goldstein,Frazer & Murphy (1997) Summary page 1.
- K981311: Cowboy XV, Kci New Technologies, Inc. (1999) Summary page 1.
- K003828: Vaso Press DVT Foot Garment #VP 520, Britt Corp., Inc. (2001) Summary page 1.
- K000303: Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Garments for the Limb, Healthcare Service and Supply (2000) Summary page 1.
- K992454: Venaflow System, Model 30A, Aircast, Inc. (2000) Summary page 1.
- K023800: Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017, Aircast, Inc. (2003) Summary page 1.
- K961405: Alba Health Pas Wrap System, Alba-Waldensian, Inc. (1996) Summary page 1.
- K012597: Sterilmed Reprocessed Compression Sleeves, Sterilmed, Inc. (2002) Summary page 1.
- K012403: Vanguard Reprocessed Compression Garment, Vanguard Medical Concepts, Inc. (2001) Summary page 1.

## Indications for use
SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.

Source page: https://510kreport.com/device/K052691
Methodology: https://510kreport.com/methodology