510(k) · Cleared
ClearedVenaOne
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vena Group, LLC · JOW Sleeve, Limb, Compressible
Cleared on Jul 2, 2020 as substantially equivalent to K130174 (Ossur Americas, Inc., 2013) and 1 other predicate after a 148-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- Jul 2, 2020
- Review
- 148 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K915638 (1992). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- 4 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- 3 generations backK061125 Dvtcare CA5Doctors Orders · 2006
- 2 generations backK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- 1 generation backK130174 Dvtcare CA5Ossur Americas, Inc. · 2013
- This deviceK200285 VenaOneVena Group, LLC · 2020
- Descendant · cites it directly · 0 of its ownK212731 Circul8 ProOrtho8, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212731Circul8 ProOrtho8, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| −4 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| −3 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| −2 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| −1 | K130174 | Dvtcare CA5 | Ossur Americas, Inc. | 2013 | — |
| 0 (this device) | K200285 | VenaOne | Vena Group, LLC | 2020 | — |
| +1 | K212731 | Circul8 Pro | Ortho8, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K130174 | Dvtcare CA5Summary page 4…ascular Product Code: JOW Regulation Number: 21 CFR 870.5800 Device Class: II Use: Prescription 3. Predicate device Primary Predicate Device: DVTCare CA5 510(k) Number: K130174 Clearance Date: May 2, 2013 Submitter: Ossur Americas Inc. Predicate/Reference Device: Cirona 6400 Disposable Deep Vein Thrombos… | 2013 |
| * | K161209 | Cirona 6400Summary page 4…0174 Clearance Date: May 2, 2013 Submitter: Ossur Americas Inc. Predicate/Reference Device: Cirona 6400 Disposable Deep Vein Thrombosis Prevention System 510(k) Number: K161209 Clearance Date: May 31, 2016 Submitter: Devon Medical Products 4. Description of Subject Device The VenaOne is a lightweight, po… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212731 | Circul8 Pro | 2021 | 0 |
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 28 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K212731 (Ortho8, Inc., 2021) has gone furthest, with 0 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. 2020, 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?
VenaOne is an easy to use system prescribed by healthcare professionals for stimulating blood flow in the legs (simulating muscle contractions) that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200285: VenaOne.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200285
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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