510(k) · Cleared
ClearedVenowave Models VW5-6, VW5-10, VW5-20 and VW5-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venowave, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Mar 7, 2008 as substantially equivalent to K060146 (Medical Compression Systems (Dbn), Ltd., 2006) after a 133-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 7, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944567 (1995). 10 ancestors in all, the oldest K915092 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 3 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 2 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 1 generation backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- This deviceK073028 Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30Venowave, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK232640 Venowave VW5Thermabright · 2024
- Descendant · cites it directly · 0 of its ownK192337 ZerovenoDimedi Co., Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −3 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −2 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −1 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| 0 (this device) | K073028 | Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30 | Venowave, Inc. | 2008 | — |
| +1 | K232640 | Venowave VW5 | Thermabright | 2024 | — |
| +1 | K192337 | Zeroveno | Dimedi Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K060146 | Activecare ++ SystemSummary page 1…tion No. 870.5800 Panel: Cardiovascular Predicate Device: Medical Compression Systems (DBN) Ltd.'s ActiveCare++System approved for marketing under K060146. Venowave Inc 13231 Kennedy Road,… | 2006 |
What descends from it? (2)
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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K232640 (Thermabright, 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K060146.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Management of the symptoms of post thrombotic syndrome (PTS)
Prevention of deep vein thrombosis, (DVT)
Prevention of primary thrombosis
Treatment of lymphedema
Diminishing post-operative pain and swelling
Treatment of leg swelling due to vascular insufficiency
Treatment of varicose veins
Treatment of chronic venous insufficiency
Enhancing blood circulation
Treatment of intermittent claudication
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073028: Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073028
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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