# K031189: Uuhc Reprocessed Compression Sleeve Devices

- Pathway: 510(k) (Traditional)
- Applicant: University of Utah Hospitals and Clinics
- Decided: Oct 16, 2003 after 184 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 K890938 (1989). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890938: Kendall SCD Therapeutic System, Kendall Healthcare Products Co. Div.Of Tyco Health (1989) Summary page 1.

## Cited in the summary but kept off the family tree
- K094664: Kendall model 6325 Compression Sleeve Device. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K121145: Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical Reprocessed Aircast Venaflow Thigh Garme (2012), 0 descendants of its own
- K080551: University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve Device (2008), 0 descendants of its own

## Indications for use
University of Utah Hospital and Clinics (UrnrC) reprocessing methods do not change the intended use of the compression sleeve devices (CSDs) from the intended use of, Kendall’s K890938 model 5325 and K94 64 model 6325 predicate devices. Both UUHC’s reprocessed device and Kendall’s predicate CSDs are intended to be placed on the intact skin of the patient’s limb and to be periodically inflated for preventing pooling of blood in the patient’s limb.

Source page: https://510kreport.com/device/K031189
Methodology: https://510kreport.com/methodology