510(k) · Cleared
Recalled · 2008Vanguard Reprocessed Compression Garments (Hill-Rom)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Apr 4, 2006 as substantially equivalent to K002287 (Medical Compression Systems (Dbn), Ltd., 2000) and 2 other predicates after a 307-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 4, 2006
- Review
- 307 days
- Class
- Class II
- Product code
- JOW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K881632 (1988). 18 ancestors in all, the oldest K781357 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
- 2 generations backK974318 Healthcare Service and Supply Alp Alternating Leg Pressure Pump and…Healthcare Service and Supply · 1998
- 1 generation backK012403 Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001 · Recalled
- This deviceK051438 Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK100909 Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K100909Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881632 | Flowtron DVT System AC500 Pump, L501 Garment | Huntleigh Technology, Inc. | 1988 | — |
| −2 | K974318 | Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments… | Healthcare Service and Supply | 1998 | — |
| −1 | K012403 | Vanguard Reprocessed Compression Garment | Vanguard Medical Concepts, Inc. | 2001 | 6 |
| 0 (this device) | K051438 | Vanguard Reprocessed Compression Garments (Hill-Rom) | Alliance Medical, Inc. | 2006 | — |
| +1 | K100909 | Reprocessed Compression Sleeves | Ascent Healthcare Solutions | 2010 | 1 |
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 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K002287 | Wizair Compression SystemSummary page 1…* Product Code: JOW Predicate * Trade Name: Devices a Hitt-Rom ActiveCare`FM DVT -*510(k) number: K002287, K012994 [510(k) clearance received by Medical Compression Systems, Ltd.] a Va… | 2000 |
| * | K012994 | Wizair DVTSummary page 1…* Product Code: JOW Predicate * Trade Name: Devices a Hitt-Rom ActiveCare`FM DVT -*510(k) number: K002287, K012994 [510(k) clearance received by Medical Compression Systems, Ltd.] a Vanguard Re… | 2002 |
| * | K012403 | Vanguard Reprocessed Compression GarmentSummary page 1…by Medical Compression Systems, Ltd.] a Vanguard Reprocessed Compression Gannrents -> 5 10(k) number: K012403 Indications When coupled with an appropriate inflation system, compression garments for Use are intended to increase ve… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100909 | Reprocessed Compression Sleeves | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2008 | Not classified | Z-1665-2008 | Process control | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K100909 (Ascent Healthcare Solutions, 2010) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K002287.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051438: Vanguard Reprocessed Compression Garments (Hill-Rom).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051438
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026