510(k) · Cleared
ClearedHealthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot Garment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthcare Service and Supply · JOW Sleeve, Limb, Compressible
Cleared on May 6, 1997 after a 197-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 6, 1997
- Review
- 197 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK964188 Healthcare Service and Supply Pva (Pneumatic Venous Augmentation)…Healthcare Service and Supply · 1997
- Descendant · cites it directly · 3 of its ownK012403 Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 1 of its ownK051438 Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK140092 Currie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve…Currie Medical Specialties, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK131743 Cirona DVT Foot GarmentDevon Medical, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK100909 Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc. · 2001 · cites it directly3descendants
- K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 2006 · 2 generations on1descendant
- K140092Currie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve (All Sizes)Currie Medical Specialties, Inc. · 2014 · cites it directly0descendants
- K131743Cirona DVT Foot GarmentDevon Medical, Inc. · 2013 · cites it directly0descendants
- K100909Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964188 | Healthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot Garment | Healthcare Service and Supply | 1997 | — |
| +1 | K012403 | Vanguard Reprocessed Compression Garment | Vanguard Medical Concepts, Inc. | 2001 | 6 |
| +2 | K051438 | Vanguard Reprocessed Compression Garments (Hill-Rom) | Alliance Medical, Inc. | 2006 | 1 |
| +1 | K140092 | Currie Medical Reprocessed Alp Calf/Thigh/Foot Compression Sleeve (All Sizes) | Currie Medical Specialties, Inc. | 2014 | — |
| +1 | K131743 | Cirona DVT Foot Garment | Devon Medical, Inc. | 2013 | — |
| +2 | K100909 | Reprocessed Compression Sleeves | Ascent Healthcare Solutions | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012403 (Vanguard Medical Concepts, Inc., 2001) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K964188 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964188: Healthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot Garment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964188
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026