510(k) · Cleared
ClearedVenowave VW5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermabright · JOW Sleeve, Limb, Compressible
Cleared on Jun 25, 2024 as substantially equivalent to K073028 (Venowave, Inc., 2008) after a 305-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 25, 2024
- Review
- 305 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944567 (1995). 11 ancestors in all, the oldest K915092 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 4 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 3 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 2 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- 1 generation backK073028 Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30Venowave, Inc. · 2008
- This deviceK232640 Venowave VW5Thermabright · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −4 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −3 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −2 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| −1 | K073028 | Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30 | Venowave, Inc. | 2008 | — |
| 0 (this device) | K232640 | Venowave VW5 | Thermabright | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K073028 | Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30Summary page 4…Generating Device Classification Name: Sleeve, Limb Product Code: JOW Regulation No. 870.5800 III. PREDICATE DEVICE: K073028 Trade Name: Venowave VW5 IV. Device Description: The Venowave VW5 is a series of compact, battery-operated p… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K073028.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Venowave device are intended to treat the following:
Indications for Use:
• Management of the symptoms of post thrombolytic 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/K232640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232640: Venowave VW5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232640
Report an extraction error
Are you the manufacturer?
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