# K033615: Wfsi's Reprocessed Compression Sleeve Devices

- Pathway: 510(k) (Traditional)
- Applicant: Wheaton Franciscan Services Inc., Supply Chain
- Decided: Feb 13, 2004 after 88 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 K881632 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881632: Flowtron DVT System AC500 Pump, L501 Garment, Huntleigh Technology, Inc. (1988) Summary page 1.

## Indications for use
The Wheaton Franciscan Huntleigh Reprocessed Compression Sleeve is recommended for use in patients for whom external compression therapy using the Huntleigh Flowtron® System is indicated for the prevention of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombus formation. Intra-operative compression therapy is frequently indicated, sometimes adjunctively with medical measures, during orthopedic, trauma, urologic and general surgery, particularly in patients over the age of 40.

Source page: https://510kreport.com/device/K033615
Methodology: https://510kreport.com/methodology