510(k) · Cleared
ClearedCowboy XV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kci New Technologies, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Apr 23, 1999 as substantially equivalent to K944567 (Kinetic Concepts, Inc., 1995) after a 378-day review. Its family tree reaches back 1 generation to 1995. 88 later devices descend from it.
- Decided
- Apr 23, 1999
- Review
- 378 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944567 (1995). 88 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- This deviceK981311 Cowboy XVKci New Technologies, Inc. · 1999
- Descendant · cites it directly · 52 of its ownK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
- Descendant · cites it directly · 31 of its ownK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- Descendant · 2 generations on · 30 of its ownK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- Descendant · 2 generations on · 25 of its ownK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- Descendant · 3 generations on · 22 of its ownK133274 Vena ProInnovamed Health, LLC · 2014
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006 · cites it directly52descendants
- K993758Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000 · cites it directly31descendants
- K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · 2 generations on30descendants
- K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · 2 generations on25descendants
- K133274Vena ProInnovamed Health, LLC · 2014 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| 0 (this device) | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| +1 | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | Thermotek, Inc. | 2006 | — |
| +1 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| +2 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| +2 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| +3 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 5 | 0 |
| 2008 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 10 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K944567 | Cowboy XSummary page 2…it Is a pneumnatic compression device used for non-ambulatory, resting patients who require increased blood flow in the calf and foot. The 510(k) number for Cowboy Xis: K944567 DEVICE DESCRIPTION Vi e e ————— [As Required by 21 CFR 807.92 a(4)] General The Cowboy XV pump is connected through tubing t… | 1995 |
What descends from it? (88)
See all 888 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | 2006 | 52 |
| K993758 | Proair 3000 Compression System | 2000 | 31 |
| K122609 | Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model… | 2012 | 3 |
| K012403 | Vanguard Reprocessed Compression Garment | 2001 | 3 |
| K150806 | PulseFlowDF | 2015 | 0 |
| K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs | 2010 | 0 |
| K101330 | Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest… | 2010 | 0 |
| K052691 | Suretek Medical Reprocessed Compression Sleeves | 2006 | 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?
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 Cowboy XV is designed to enhance blood circulation in the venules and arterioles in patients with diabetic ulcers of the lower extremities.
Cowboy XV is intended for patient’s in the home who would benefit from increased blood flow to:
treat and assist healing of cutaneous ulceration (wounds).
reduce wound healing time.
enhance arterial circulation (blood flow).
prevent venous stasis (slowing of blood flow).
reduce compartmental pressures.
reduce edema (swelling).
reduce post-operative pain and swelling.
reduce the need for anticoagulant medications (medications that thin the blood).
prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981311 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981311: Cowboy XV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981311
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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