510(k) · Cleared
ClearedTripleplay-VT Vascular Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wildcat Medical, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Jan 26, 2011 as substantially equivalent to K061866 (Thermotek, Inc., 2006) and 4 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1992. 25 later devices descend from it.
- Decided
- Jan 26, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K915638 (1992). 14 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- 2 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- 1 generation backK061125 Dvtcare CA5Doctors Orders · 2006
- This deviceK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- Descendant · cites it directly · 22 of its ownK133274 Vena ProInnovamed Health, LLC · 2014
- Descendant · 2 generations on · 5 of its ownK151189 Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products · 2015
- Descendant · 2 generations on · 4 of its ownK160318 PlasmaFlowManamed, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK193020 VenaPro Vascular Therapy SystemInnovamed Health, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK142728 ActiveCare+SFT; ActiveCare+SFT HomeCare…Medical Compressions System (Dbn), Ltd. · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K133274Vena ProInnovamed Health, LLC · 2014 · cites it directly22descendants
- K151189Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products · 2015 · 2 generations on5descendants
- K160318PlasmaFlowManamed, Inc. · 2016 · 2 generations on4descendants
- K193020VenaPro Vascular Therapy SystemInnovamed Health, LLC · 2019 · 2 generations on2descendants
- K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd. · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| −2 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| −1 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| 0 (this device) | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| +1 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| +2 | K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System | Devon Medical Products | 2015 | — |
| +2 | K160318 | PlasmaFlow | Manamed, Inc. | 2016 | — |
| +2 | K193020 | VenaPro Vascular Therapy System | Innovamed Health, LLC | 2019 | — |
| +2 | K142728 | ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category)… | Medical Compressions System (Dbn), Ltd. | 2014 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 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 |
|---|---|---|---|
| * | K061866 | Nanotherm, Vascutherm and Prothermo Therapy WrapsSummary page 2…K103 19? Identification of Predicate Devices ThermoTek, Inc., NanoTherm and VascuThermi K06 1866 Doctor's Orders, Inc., DVTCare CA5 K061 125 Medical Compression Systems, LTD, WizAir… | 2006 |
| * | K061125 | Dvtcare CA5Summary page 2…Predicate Devices ThermoTek, Inc., NanoTherm and VascuThermi K06 1866 Doctor's Orders, Inc., DVTCare CA5 K061 125 Medical Compression Systems, LTD, WizAir DVT K023 573 Dynamic Air, Inc., TravelAir Portable Co… | 2006 |
| * | K023573 | Wizair Compression SystemSummary page 2…K06 1866 Doctor's Orders, Inc., DVTCare CA5 K061 125 Medical Compression Systems, LTD, WizAir DVT K023 573 Dynamic Air, Inc., TravelAir Portable Compression System… | 2002 |
| * | K022340 | Travelair Portable Compression SystemSummary page 2…TD, WizAir DVT K023 573 Dynamic Air, Inc., TravelAir Portable Compression System K022340 Microtek Medical, Inc., Venodyne DVT Advantage Plus K(01… | 2003 |
| * | K011318 | Venodyne DVT Advantage PlusSummary page 2…K022340 Microtek Medical, Inc., Venodyne DVT Advantage Plus K(011318 Device Description The TriplePlay-VT Vascular Therapy System is a lightweight, portable, rechargeable battery powered… | 2001 |
What descends from it? (25)
See all 252 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 19 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K133274 (Innovamed Health, LLC, 2014) has gone furthest, with 22 descendants of its own.
- 8 other devices also cite its predicate K061866.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 TriplePlay-VT, model TPVT-Ol (supplied with a pair of model TP-3333 "cuffs") is intended to be an easy to use portable system, prescribed by a physician, 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…
Read the full statement (127 words)
The TriplePlay-VT, model TPVT-Ol (supplied with a pair of model TP-3333 "cuffs") is intended to be an easy to use portable system, prescribed by a physician, 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/K103187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103187: Tripleplay-VT Vascular Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103187
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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