510(k) · Cleared
ClearedVena Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovamed Health, LLC · JOW Sleeve, Limb, Compressible
Cleared on Feb 12, 2014 as substantially equivalent to K103187 (Wildcat Medical, Inc., 2011) and 4 other predicates after a 111-day review. Its family tree reaches back 4 generations to 1992. 22 later devices descend from it.
- Decided
- Feb 12, 2014
- Review
- 111 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K915638 (1992). 15 ancestors in all. 22 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- 3 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- 2 generations backK061125 Dvtcare CA5Doctors Orders · 2006
- 1 generation backK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- This deviceK133274 Vena ProInnovamed Health, LLC · 2014
- Descendant · cites it directly · 5 of its ownK151189 Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products · 2015
- Descendant · cites it directly · 4 of its ownK160318 PlasmaFlowManamed, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK193020 VenaPro Vascular Therapy SystemInnovamed Health, LLC · 2019
- Descendant · cites it directly · 2 of its ownK142728 ActiveCare+SFT; ActiveCare+SFT HomeCare…Medical Compressions System (Dbn), Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK203310 SyneCare 1000 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd. · 2021
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K151189Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products · 2015 · cites it directly5descendants
- K160318PlasmaFlowManamed, Inc. · 2016 · cites it directly4descendants
- K193020VenaPro Vascular Therapy SystemInnovamed Health, LLC · 2019 · cites it directly2descendants
- K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd. · 2014 · cites it directly2descendants
- K203310SyneCare 1000 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd. · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| −3 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| −2 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| −1 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| 0 (this device) | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| +1 | K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System | Devon Medical Products | 2015 | — |
| +1 | K160318 | PlasmaFlow | Manamed, Inc. | 2016 | — |
| +1 | K193020 | VenaPro Vascular Therapy System | Innovamed Health, LLC | 2019 | — |
| +1 | K142728 | ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category)… | Medical Compressions System (Dbn), Ltd. | 2014 | — |
| +1 | K203310 | SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System | Jiangsu Synecoun Medical Technology Co., Ltd. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K103187 | Tripleplay-VT Vascular Therapy SystemSummary page 2…October 22, 2013 Identification of Predicate Devices Wildcat Medical Equipment, Inc., TriplePlay TPVT-O1 K103 187 Doctor's Orders, Inc., DVTCare CAS K061 125 Medical Compression Systems, LTD, WizAir DV… | 2011 |
| * | K061125 | Dvtcare CA5Summary page 2…n of Predicate Devices Wildcat Medical Equipment, Inc., TriplePlay TPVT-O1 K103 187 Doctor's Orders, Inc., DVTCare CAS K061 125 Medical Compression Systems, LTD, WizAir DVT K023573 Dynamic Air, Inc., TravelAir Portable Compre… | 2006 |
| * | K023573 | Wizair Compression SystemSummary page 2…T-O1 K103 187 Doctor's Orders, Inc., DVTCare CAS K061 125 Medical Compression Systems, LTD, WizAir DVT K023573 Dynamic Air, Inc., TravelAir Portable Compression System K02… | 2002 |
| * | K022340 | Travelair Portable Compression SystemSummary page 2…ms, LTD, WizAir DVT K023573 Dynamic Air, Inc., TravelAir Portable Compression System K022340 Microtek Medical, Inc., Venodyne DVT Advantage Plus KO0113… | 2003 |
| * | K011318 | Venodyne DVT Advantage PlusSummary page 3…principals to achieve identical results. All predicate systems (DVTCare CAS-K061 125, TriplePlay-K103187, WizAir DVT-K023S73, TravelAir-K022340 and Venodyne DVTAdvantage-K01 1318) utilize microprocessor controlled pumps to deliver approximately 50 mmHg of pressurized air to bladders that are attached to the… | 2001 |
What descends from it? (22)
See all 227 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System | 2015 | 5 |
| K160318 | PlasmaFlow | 2016 | 4 |
| K193020 | VenaPro Vascular Therapy System | 2019 | 2 |
| K142728 | ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx… | 2014 | 2 |
| K203310 | SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System | 2021 | 1 |
| K180248 | VascuEase IC-1200-WH | 2018 | 1 |
| K151158 | ALP VasQcare Take Home System | 2015 | 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 22 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K151189 (Devon Medical Products, 2015) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K103187.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Vena Pro Vascular Therapy System, model VP-31 1l, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to: Aid in the prevention of DVT; Enhance blood circulation; Diminish post-operative pain and swelling; Reduce wound healing time; Aid in…
Read the full statement (127 words)
The Vena Pro Vascular Therapy System, model VP-31 1l, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:
Aid in the prevention of DVT;
Enhance blood circulation;
Diminish post-operative pain and swelling;
Reduce wound healing time;
Aid 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.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133274: Vena Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133274
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