# K080551: University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve Device

- Pathway: 510(k) (Traditional)
- Applicant: University of Utah Hospitals and Clinics
- Decided: May 28, 2008 after 90 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 K012417 (2002). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000303: Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Garments for the Limb, Healthcare Service and Supply (2000) Summary page 1.
- K051227: Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1, Renu Medical, Inc. (2006) Summary page 1.
- K031189: Uuhc Reprocessed Compression Sleeve Devices, University of Utah Hospitals and Clinics (2003) Summary page 1.

## Indications for use
The University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device reprocessing methods do not change the intended use of the original manufacturer Healthcare Service and Supply ALP® (K000303) alternating leg pressure sleeve device. Both are sequential compression sleeves to be used by patients as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.

Source page: https://510kreport.com/device/K080551
Methodology: https://510kreport.com/methodology