# K012654: Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20, DVT 30, DVT 40

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: Apr 12, 2002 after 242 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
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Huntleigh Flowtron® DVT Garment: named in the summary without a submission number

## Most influential descendants
- K031559: Renu Medical Reporcessed Compressible Limb Sleeves (2003), 4 descendants of its own
- K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs (2006), 3 descendants of its own
- K051227: Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1 (2006), 2 descendants of its own
- K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs (2009), 1 descendant of its own
- K203847: Reprocessed Tri Pulse Compression Garment (2021), 0 descendants of its own

## Indications for use
The Hygia Health Services Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.

Source page: https://510kreport.com/device/K012654
Methodology: https://510kreport.com/methodology