510(k) · Cleared

Recalled · Class II · 2017

Vanguard Reprocessed Compression Garment

K012403510(k) TraditionalCleared Oct 17, 200179-day reviewClass II21 CFR 870.5800Recalls 6

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vanguard Medical Concepts, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Oct 17, 2001 as substantially equivalent to K781357 (Kendall Research Center, 1978) and 14 other predicates after a 79-day review. Its family tree reaches back 2 generations to 1988. 3 later devices descend from it. It has been recalled 6 times.

Decided: Oct 17, 2001
Review: 79 days
Class: Class II
Product code: JOW
Recalls: 6
Predicates: 15

Its longest line of descent runs back 2 generations to K881632 (1988). 15 ancestors in all, the oldest K781357 (1978). 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
1 generation backK974318 Healthcare Service and Supply Alp Alternating Leg Pressure Pump and…Healthcare Service and Supply · 1998
This deviceK012403 Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001
Descendant · cites it directly · 1 of its ownK051438 Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 2006 · Recalled
Descendant · cites it directly · 0 of its ownK100909 Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · Recalled
Descendant · cites it directly · 0 of its ownK052691 Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006

Most influential descendants

Showing 3 of 3 · See all

K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 2006 · cites it directly1descendant
K100909Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · cites it directly0descendants
K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K881632	Flowtron DVT System AC500 Pump, L501 Garment	Huntleigh Technology, Inc.	1988	—
−1	K974318	Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments…	Healthcare Service and Supply	1998	—
0 (this device)	K012403	Vanguard Reprocessed Compression Garment	Vanguard Medical Concepts, Inc.	2001	—
+1	K051438	Vanguard Reprocessed Compression Garments (Hill-Rom)	Alliance Medical, Inc.	2006	1
+1	K100909	Reprocessed Compression Sleeves	Ascent Healthcare Solutions	2010	1
+1	K052691	Suretek Medical Reprocessed Compression Sleeves	Suretek Medical	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1986	1	0
1989	1	0
1993	2	0
1995	2	0
1996	2	0
1997	1	0
1999	2	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2010	1	0

FIG. 1 — Lineage of K012403, 1988–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOW device

#1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (15)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K781357	T.E.D. Sequential Compression Sleeves Summary page 1 …all SCD™ Sequential Compression Sleeves and ImPad™ Rigid Sole Devices Foot Covers believed to be legally marketed under various possible 510(k) premarket notifications (K781357, K863581, K890938, K932835, K942664, K992079) ¢ Huntleigh Healthcare DVT Garments believed to be legally marketed under a couple…	Kendall Research Center	1978	1
*	K863581	Modified Model 5320 T.E.D. Compression Limb Summary page 1 …Sequential Compression Sleeves and ImPad™ Rigid Sole Devices Foot Covers believed to be legally marketed under various possible 510(k) premarket notifications (K781357, K863581, K890938, K932835, K942664, K992079) ¢ Huntleigh Healthcare DVT Garments believed to be legally marketed under a couple of possi…	The Kendal Co.	1986	—
*	K890938	Kendall SCD Therapeutic System Summary page 1 …l Compression Sleeves and ImPad™ Rigid Sole Devices Foot Covers believed to be legally marketed under various possible 510(k) premarket notifications (K781357, K863581, K890938, K932835, K942664, K992079) ¢ Huntleigh Healthcare DVT Garments believed to be legally marketed under a couple of possible 510(k…	Kendall Healthcare Products Co. Div.Of Tyco Health	1989	—
*	K932835	Kendall T.E.D./SCD Sequential Compression Device Summary page 1 …sion Sleeves and ImPad™ Rigid Sole Devices Foot Covers believed to be legally marketed under various possible 510(k) premarket notifications (K781357, K863581, K890938, K932835, K942664, K992079) ¢ Huntleigh Healthcare DVT Garments believed to be legally marketed under a couple of possible 510(k) premark…	Kendall Healthcare Products Co. Div.Of Tyco Health	1993	—
*	K942664	Kendall Model 6325 SCD Sequel Compression System Summary page 1 …ves and ImPad™ Rigid Sole Devices Foot Covers believed to be legally marketed under various possible 510(k) premarket notifications (K781357, K863581, K890938, K932835, K942664, K992079) ¢ Huntleigh Healthcare DVT Garments believed to be legally marketed under a couple of possible 510(k) premarket notifi…	The Kendal Co.	1995	—
*	K992079	Kendall Model 7325 SCD Response Compression System, Model 7325 Summary page 1 …mPad™ Rigid Sole Devices Foot Covers believed to be legally marketed under various possible 510(k) premarket notifications (K781357, K863581, K890938, K932835, K942664, K992079) ¢ Huntleigh Healthcare DVT Garments believed to be legally marketed under a couple of possible 510(k) premarket notifications (…	The Kendall Company, L.P.	1999	—
*	K881632	Flowtron DVT System AC500 Pump, L501 Garment Summary page 1 …3581, K890938, K932835, K942664, K992079) ¢ Huntleigh Healthcare DVT Garments believed to be legally marketed under a couple of possible 510(k) premarket notifications (K881632 K961166) e Aircast® VenaFlow® Cuffs believed to be legally marketed under the possible 510(k) premarket notification K932900 e…	Huntleigh Technology, Inc.	1988	—
*	K961166	Flowtron Excel Pump Summary page 1 …90938, K932835, K942664, K992079) ¢ Huntleigh Healthcare DVT Garments believed to be legally marketed under a couple of possible 510(k) premarket notifications (K881632 K961166) e Aircast® VenaFlow® Cuffs believed to be legally marketed under the possible 510(k) premarket notification K932900 e Nutech®P…	Hne Healthcare, Inc.	1996	—
*	K932900	Aircast Venaflow System Summary page 1 …of possible 510(k) premarket notifications (K881632 K961166) e Aircast® VenaFlow® Cuffs believed to be legally marketed under the possible 510(k) premarket notification K932900 e Nutech®PlexiPulse® Wraps believed to be legally marketed under a couple of possible 510(k) premarket notifications (K944567, K…	Aircast, Inc.	1993	—
*	K944567	Cowboy X Summary page 1 …the possible 510(k) premarket notification K932900 e Nutech®PlexiPulse® Wraps believed to be legally marketed under a couple of possible 510(k) premarket notifications (K944567, K981311) Continued on next page Microvasive and Radial Jaw are registered trademarks of Boston Scientific Corporation V - Page…	Kinetic Concepts, Inc.	1995	1
*	K981311	Cowboy XV Summary page 1 …ble 510(k) premarket notification K932900 e Nutech®PlexiPulse® Wraps believed to be legally marketed under a couple of possible 510(k) premarket notifications (K944567, K981311) Continued on next page Microvasive and Radial Jaw are registered trademarks of Boston Scientific Corporation V - Page 1 of 3 P…	Kci New Technologies, Inc.	1999	—
*	K955853	Healthcare Service & Supply Pump Alp 501 Pump System Summary page 2 …thcare Service & Supply ALP® Alternating Leg Pressure® Garments Devicw, believed to be legally marketed under various possible 5 10(k) premarket continued notifications (K955853. K964188. K974318, K000303) Indications for When coupled with an appropriate inflation system, compression garments Use are in…	Healthcare Service and Supply	1996	—
*	K964188	Healthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot Garment Summary page 2 …rvice & Supply ALP® Alternating Leg Pressure® Garments Devicw, believed to be legally marketed under various possible 5 10(k) premarket continued notifications (K955853. K964188. K974318, K000303) Indications for When coupled with an appropriate inflation system, compression garments Use are intended to…	Healthcare Service and Supply	1997	—
*	K974318	Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb Summary page 2 …upply ALP® Alternating Leg Pressure® Garments Devicw, believed to be legally marketed under various possible 5 10(k) premarket continued notifications (K955853. K964188. K974318, K000303) Indications for When coupled with an appropriate inflation system, compression garments Use are intended to increase…	Healthcare Service and Supply	1998	—
*	K000303	Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Garments for the Limb Summary page 2 …® Alternating Leg Pressure® Garments Devicw, believed to be legally marketed under various possible 5 10(k) premarket continued notifications (K955853. K964188. K974318, K000303) Indications for When coupled with an appropriate inflation system, compression garments Use are intended to increase venous r…	Healthcare Service and Supply	2000	—

Also cleared against K781357: 4 other devices →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051438	Vanguard Reprocessed Compression Garments (Hill-Rom)	Alliance Medical, Inc.	2006	1
K100909	Reprocessed Compression Sleeves	Ascent Healthcare Solutions	2010	0
K052691	Suretek Medical Reprocessed Compression Sleeves	Suretek Medical	2006	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 1, 2017	Class II	Z-0272-2018	Packaging	3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.
Mar 11, 2008	Not classified	Z-1666-2008	Process control	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	Process control	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	Process control	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	Process control	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	Process control	Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
2 of the 15 ancestors have a recall of any class.
Of its descendants, K051438 (Alliance Medical, Inc., 2006) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K781357.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOW

7in 2025

2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	66	0	12
2008	4	112	7	36
2009	3	84	0	45
2010	18	71	2	66
2011	11	104	3	50
2012	13	63	2	100
2013	17	94	0	169
2014	16	91	0	93
2015	10	160	0	137
2016	9	121	0	150
2017	9	116	1	149
2018	11	136	0	114
2019	11	88	1	102
2020	14	158	0	50
2021	16	132	0	34
2022	7	80	0	27
2023	6	160	0	57
2024	8	197	0	30
2025	7	168	0	24
2026	6	252	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012403 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012403: Vanguard Reprocessed Compression Garment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012403

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026