510(k) · Cleared
ClearedVpulse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cothera, LLC · JOW Sleeve, Limb, Compressible
Cleared on Feb 22, 2013 as substantially equivalent to K061866 (Thermotek, Inc., 2006) after a 177-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Feb 22, 2013
- Review
- 177 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944567 (1995). 8 ancestors in all, the oldest K942796 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −2 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −1 | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | Thermotek, Inc. | 2006 | — |
| 0 (this device) | K122640 | Vpulse | Cothera, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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? (1)
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 3…lt of surgery. The SCT wraps are typically applied to the calves. Predicate Device(s): Predicate devices cited include the Thermotek NanoThem and VascuThermaTM (K06 1866). I ubect Device jPredicate Devices Manufacturer ICothera… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 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. 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 VPULSE is intended to function as an intermittent, external compression device in extremities to prevent and reduce complications of poor circulation. This includes: * deep vein thrombosis, * chronic venous insufficiency, * venous stasis ulcers, * post-mastectomy edema and chronic lymphedema, * reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains, * localized cold thermal therapy for…
Read the full statement (113 words)
The VPULSE is intended to function as an intermittent, external compression device in extremities to prevent and reduce complications of poor circulation. This includes:
* deep vein thrombosis,
* chronic venous insufficiency,
* venous stasis ulcers,
* post-mastectomy edema and chronic lymphedema,
* reduction of edema associated with soft tissue injuries such as burns,
postoperative edema, and ligament sprains,
* localized cold thermal therapy for post-traumatic and post-surgical medical
and/or surgical conditions)
* Aids the blood flow back to the heart
* Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing
time, enhance arterial circulation (blood flow), reduce compartmental pressures,
reduce edema (swelling), reduce the need for anticoagulant (blood thinning)
medications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122640: Vpulse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122640
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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