510(k) · Cleared
ClearedCalf Garment DVT10(S) Compressible Limb Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare, Inc. · JOW Sleeve, Limb, Compressible
Cleared on May 7, 1993 after a 176-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 7, 1993
- Review
- 176 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK925717 Calf Garment DVT10(S) Compressible Limb SleeveHuntleigh Healthcare, Inc. · 1993
- Descendant · cites it directly · 3 of its ownK022786 DVT60Huntleigh Healthcare, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK172103 Flowtron DVT5 Small Calf GarmentGetinge (Suzhou) Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010
- Descendant · 2 generations on · 0 of its ownK052691 Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006
Most influential descendants
Showing 5 of 5 · See all- K022786DVT60Huntleigh Healthcare, Inc. · 2002 · cites it directly3descendants
- K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009 · 2 generations on1descendant
- K172103Flowtron DVT5 Small Calf GarmentGetinge (Suzhou) Co., Ltd. · 2018 · cites it directly0descendants
- K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010 · 3 generations on0descendants
- K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925717 | Calf Garment DVT10(S) Compressible Limb Sleeve | Huntleigh Healthcare, Inc. | 1993 | — |
| +1 | K022786 | DVT60 | Huntleigh Healthcare, Inc. | 2002 | — |
| +2 | K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs | Hygia Health Services, Inc. | 2009 | — |
| +1 | K172103 | Flowtron DVT5 Small Calf Garment | Getinge (Suzhou) Co., Ltd. | 2018 | — |
| +3 | K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs | Midwest Reprocessing Center, LLC | 2010 | — |
| +2 | K052691 | Suretek Medical Reprocessed Compression Sleeves | Suretek Medical | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 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? (5)
2 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, K022786 (Huntleigh Healthcare, Inc., 2002) 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/K925717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925717: Calf Garment DVT10(S) Compressible Limb Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925717
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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