510(k) · Cleared
ClearedDvtcare CA5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doctors Orders · JOW Sleeve, Limb, Compressible
Cleared on May 23, 2006 as substantially equivalent to K023573 (Medical Compression Systems (Dbn), Ltd., 2002) and 3 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1992. 30 later devices descend from it.
- Decided
- May 23, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K915638 (1992). 6 ancestors in all. 30 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- 1 generation backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- This deviceK061125 Dvtcare CA5Doctors Orders · 2006
- Descendant · cites it directly · 25 of its ownK103187 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
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · cites it directly25descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| −1 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| 0 (this device) | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K023573 | Wizair Compression SystemSummary page 2…f Substantial Equivalence: The DVTcareTM CA5 is substantially equivalent to the following commercially available devices: WizA ir DVT (5 10k number: K023 573) in that the basis of operation of both devices uses intermittent, pneumatic compression to simulate muscle contrac… | 2002 |
| * | K022340 | Travelair Portable Compression SystemSummary page 2…tions for use are similar. Cycle operating parameters are similar in pressure delivery and cycle time. TravelAir Portable Compression System (51l0k number: K022340) in that the basis of operation of both devices uses intermittent, pneumatic compression to simulate muscle contracti… | 2003 |
| * | K011318 | Venodyne DVT Advantage Plus | 2001 |
| * | K961166 | Flowtron Excel PumpSummary page 3…D\/TCare, LLC 731 Construction Ct. Suite B Zeeland, MI 49464 Flowtron ExcelAC550 (510k number: K961166) is similar in operation and intended use to the DVTCare CA5. Both incorporate adjustable pressures (between 20mmHg… | 1996 |
What descends from it? (30)
See all 308 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103187 | Tripleplay-VT Vascular Therapy System | 2011 | 25 |
| K133274 | Vena Pro | 2014 | 22 |
| K130174 | Dvtcare CA5 | 2013 | 2 |
| K151158 | ALP VasQcare Take Home System | 2015 | 0 |
| K121376 | Compression Care Flight | 2012 | 0 |
| K111748 | Recovery+ Model PS 511, Dvtherapy Model PS 511A | 2011 | 0 |
| K111720 | Aviafit | 2011 | 0 |
| K100969 | Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF… | 2010 | 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 14 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K103187 (Wildcat Medical, Inc., 2011) has gone furthest, with 25 descendants of its own.
- 4 other devices also cite its predicate K023573.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DVTcareTM CA5 is intended to be an easy to use, portable system that is prescribed by healthcare professionals, to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of…
Read the full statement (123 words)
The DVTcareTM CA5 is intended to be an easy to use, portable system that is prescribed by healthcare professionals, to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061125: Dvtcare CA5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061125
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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