# K051438: Vanguard Reprocessed Compression Garments (Hill-Rom)

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical, Inc.
- Decided: Apr 4, 2006 after 307 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K881632 (1988). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002287: Wizair Compression System, Medical Compression Systems (Dbn), Ltd. (2000) Summary page 1.
- K012994: Wizair DVT, Medical Compression Systems (Dbn), Ltd. (2002) Summary page 1.
- K012403: Vanguard Reprocessed Compression Garment, Vanguard Medical Concepts, Inc. (2001) Summary page 1.

## Most influential descendants
- K100909: Reprocessed Compression Sleeves (2010), 0 descendants of its own

## Recalls of this device
- Mar 11, 2008 · Not classified · Z-1665-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

## Indications for use
When coupled with an appropriate inflation system, compression garments are intended to increase venous return from the legs and feet as a prophylaxis for the formation of deep vein thrombosis (DVT) or subsequent pulmonary embolism (PE) in high risk and/or non-ambulatory patients.

Source page: https://510kreport.com/device/K051438
Methodology: https://510kreport.com/methodology