510(k) · Cleared
ClearedDVT60
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 Sep 19, 2002 as substantially equivalent to K925717 (Huntleigh Healthcare, Inc., 1993) after a 28-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Sep 19, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925717 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK925717 Calf Garment DVT10(S) Compressible Limb SleeveHuntleigh Healthcare, Inc. · 1993
- This deviceK022786 DVT60Huntleigh Healthcare, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK090074 Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010
- Descendant · cites it directly · 0 of its ownK052691 Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006
Most influential descendants
Showing 3 of 3 · See all- K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009 · cites it directly1descendant
- K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K925717 | Calf Garment DVT10(S) Compressible Limb Sleeve | Huntleigh Healthcare, Inc. | 1993 | — |
| 0 (this device) | K022786 | DVT60 | Huntleigh Healthcare, Inc. | 2002 | — |
| +1 | K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs | Hygia Health Services, Inc. | 2009 | — |
| +2 | K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs | Midwest Reprocessing Center, LLC | 2010 | — |
| +1 | K052691 | Suretek Medical Reprocessed Compression Sleeves | Suretek Medical | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K925717 | Calf Garment DVT10(S) Compressible Limb SleeveSummary page 1…0 Common Name Limb Compression Sleeves Classification Name Sleeve, Limb, Compression (JOW) Predicate Device Huntleigh Healthcare DVTlO(s) K925717/A Device Description The DVT60 Compression Sleeves are single chamber inflatable cuffs, designe… | 1993 |
What descends from it? (3)
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?
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?
The DVT60 Compression Sleeve is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022786: DVT60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022786
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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