510(k) · Cleared
ClearedDvtcare CA5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ossur Americas, Inc. · JOW Sleeve, Limb, Compressible
Cleared on May 2, 2013 as substantially equivalent to K061125 (Doctors Orders, 2006) and 1 other predicate after a 98-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- May 2, 2013
- Review
- 98 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K915638 (1992). 15 ancestors in all. 2 later devices descend from it, 1 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 deviceK130174 Dvtcare CA5Ossur Americas, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK200285 VenaOneVena Group, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK212731 Circul8 ProOrtho8, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView 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) | K130174 | Dvtcare CA5 | Ossur Americas, Inc. | 2013 | — |
| +1 | K200285 | VenaOne | Vena Group, LLC | 2020 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K061125 | Dvtcare CA5Summary page 1…ification Name: Compressible Limb Sleeve Class: I1 Product Code: JOW Regulation Number: 21 CER 870.5800 Predicate Devices: i. DVTCare CAS, Doctors Orders (K061 125), Acquired by Ossur Americas ii. TriplePlay-VT Vascular Therapy System TPVT-01, Wildcat Medical Inc (K103 187) Device Descri… | 2006 |
| * | K103187 | Tripleplay-VT Vascular Therapy SystemSummary page 1…Predicate Devices: i. DVTCare CAS, Doctors Orders (K061 125), Acquired by Ossur Americas ii. TriplePlay-VT Vascular Therapy System TPVT-01, Wildcat Medical Inc (K103 187) Device Description: The subject 'DVTCare CA5Y is a light weight, portable, prescriptive device intended to aid in preve… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200285 | VenaOne | 2020 | 1 |
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 21 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, K200285 (Vena Group, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K061125.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 DVTCare CA5 is intended to be a 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…
Read the full statement (120 words)
The DVTCare CA5 is intended to be a 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/K130174 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130174: Dvtcare CA5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130174
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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