# K012403: Vanguard Reprocessed Compression Garment

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Oct 17, 2001 after 79 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881632 (1988). 15 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781357: T.E.D. Sequential Compression Sleeves, Kendall Research Center (1978) Summary page 1.
- K863581: Modified Model 5320 T.E.D. Compression Limb, The Kendal Co. (1986) Summary page 1.
- K890938: Kendall SCD Therapeutic System, Kendall Healthcare Products Co. Div.Of Tyco Health (1989) Summary page 1.
- K932835: Kendall T.E.D./SCD Sequential Compression Device, Kendall Healthcare Products Co. Div.Of Tyco Health (1993) Summary page 1.
- K942664: Kendall Model 6325 SCD Sequel Compression System, The Kendal Co. (1995) Summary page 1.
- K992079: Kendall Model 7325 SCD Response Compression System, Model 7325, The Kendall Company, L.P. (1999) Summary page 1.
- K881632: Flowtron DVT System AC500 Pump, L501 Garment, Huntleigh Technology, Inc. (1988) Summary page 1.
- K961166: Flowtron Excel Pump, Hne Healthcare, Inc. (1996) Summary page 1.
- K932900: Aircast Venaflow System, Aircast, Inc. (1993) Summary page 1.
- K944567: Cowboy X, Kinetic Concepts, Inc. (1995) Summary page 1.
- K981311: Cowboy XV, Kci New Technologies, Inc. (1999) Summary page 1.
- K955853: Healthcare Service & Supply Pump Alp 501 Pump System, Healthcare Service and Supply (1996) Summary page 2.
- K964188: Healthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot Garment, Healthcare Service and Supply (1997) Summary page 2.
- K974318: Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb, Healthcare Service and Supply (1998) Summary page 2.
- K000303: Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Garments for the Limb, Healthcare Service and Supply (2000) Summary page 2.

## Most influential descendants
- K051438: Vanguard Reprocessed Compression Garments (Hill-Rom) (2006), 1 descendant of its own
- K100909: Reprocessed Compression Sleeves (2010), 0 descendants of its own
- K052691: Suretek Medical Reprocessed Compression Sleeves (2006), 0 descendants of its own

## Recalls of this device
- Dec 1, 2017 · Class II · Z-0272-2018: 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
- Mar 11, 2008 · Not classified · Z-1666-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- Mar 11, 2008 · Not classified · Z-1672-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- Mar 11, 2008 · Not classified · Z-1671-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- Mar 11, 2008 · Not classified · Z-1661-2008: Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- Mar 11, 2008 · Not classified · Z-1676-2008: 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. The compression garments are prescription devices intended for a single patient use only.

Source page: https://510kreport.com/device/K012403
Methodology: https://510kreport.com/methodology