510(k) Report

510(k) · Cleared

Recalled · 2009

Cowboy X

K944567510(k) TraditionalCleared Jun 21, 1995275-day reviewClass II21 CFR 870.5800Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kinetic Concepts, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Jun 21, 1995 after a 275-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 91 later devices descend from it. It has been recalled once.

Decided
Jun 21, 1995
Review
275 days
Class
Class II
Product code
JOW
Recalls
1
Predicates
0

91 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2010: 5 descendants cleared2006: 6 descendants cleared2003: 1 descendant cleared2012: 3 descendants cleared2001: 1 descendant cleared2018: 4 descendants cleared2013: 3 descendants cleared2015: 4 descendants cleared2000: 1 descendant cleared2019: 6 descendants cleared2011: 4 descendants cleared2017: 4 descendants cleared2024: 9 descendants cleared2008: 1 descendant cleared2014: 3 descendants cleared2026: 5 descendants cleared2025: 3 descendants cleared2021: 10 descendants cleared2023: 6 descendants cleared2020: 7 descendants cleared2016: 3 descendants cleared2022: 1 descendant cleared1995200020052010201520202025
  1. This deviceK944567 Cowboy XKinetic Concepts, Inc. · 1995
  2. Descendant · cites it directly · 88 of its ownK981311 Cowboy XVKci New Technologies, Inc. · 1999
  3. Descendant · 2 generations on · 52 of its ownK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
  4. Descendant · 2 generations on · 31 of its ownK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
  5. Descendant · 3 generations on · 30 of its ownK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
  6. Descendant · 3 generations on · 25 of its ownK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011

Showing 5 of 91 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12001: 12003: 12006: 62008: 12010: 52011: 42012: 32013: 32014: 32015: 42016: 32017: 42018: 42019: 62020: 72021: 102022: 12023: 62024: 92025: 32026: 5
1999high 10 (2021) · low 0 (2002)2026

Most influential descendants

Showing 5 of 91 · See all
  • K981311Cowboy XVKci New Technologies, Inc. · 1999 · cites it directly88descendants
  • K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006 · 2 generations on52descendants
  • K993758Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000 · 2 generations on31descendants
  • K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · 3 generations on30descendants
  • K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · 3 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944567Cowboy XKinetic Concepts, Inc.1995—
+1K981311Cowboy XVKci New Technologies, Inc.1999—
+2K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc.2006—
+2K993758Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd.2000—
+3K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd.20061
+3K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200110
200310
200660
200810
201050
201140
201230
201330
201430
201540
201630
201740
201840
201960
202070
2021100
202210
202360
202490
202530
202650
FIG. 1 — Lineage of K944567, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (91)

See all 91

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981311Cowboy XVKci New Technologies, Inc.199988
K122609Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model…Venous Health Systems, Inc.20123
K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.20013
K060091Alliance Medical Corporation Reprocessed Compression SleevesAlliance Medical Corp.20061
K024087Reprocessed Compression SleevesAlliance Medical Corp.20031
K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC20100
K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 4, 2009Not classifiedZ-0663-2010Nonconforming Material/ComponentPower cords may crack and fail inside plug with potential for fire hazard.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K981311 (Kci New Technologies, Inc., 1999) has gone furthest, with 88 descendants of its own.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOW

7in 2025

2007: 62008: 42009: 32010: 182011: 112012: 132013: 172014: 162015: 102016: 92017: 92018: 112019: 112020: 142021: 162022: 72023: 62024: 82025: 72026 (partial year): 6
2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007: 66 days median2008: 112 days median2009: 84 days median2010: 71 days median2011: 104 days median2012: 63 days median2013: 94 days median2014: 91 days median2015: 160 days median2016: 121 days median2017: 116 days median2018: 136 days median2019: 88 days median2020: 158 days median2021: 132 days median2022: 80 days median2023: 160 days median2024: 197 days median2025: 168 days median2026 (partial year): 252 days median
2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2008: 72010: 22011: 32012: 22017: 12019: 1
2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007: 122008: 362009: 452010: 662011: 502012: 1002013: 1692014: 932015: 1372016: 1502017: 1492018: 1142019: 1022020: 502021: 342022: 272023: 572024: 302025: 24
2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007666012
20084112736
2009384045
20101871266
201111104350
201213632100
201317940169
20141691093
2015101600137
201691210150
201791161149
2018111360114
201911881102
202014158050
202116132034
2022780027
20236160057
20248197030
20257168024
202662520—

More from Kinetic Concepts, Inc.

48 FDA decisions under this applicant name. See the company

  • K050261V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc. · 2005
  • K041642V.a.C. Granufoam Silver DressingKinetic Concepts, Inc. · 2005
  • K032310Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 20032 recalls
  • K022011V.a.C. Abdominal DressingKinetic Concepts, Inc. · 20031 recall
  • K021500Vacuum Assisted ClosureKinetic Concepts, Inc. · 2002

Recent decisions in JOW

The JOW category page

  • K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc. · 2026
  • K254217AerloomEvolym, LLC · 2026
  • K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
  • K253386DVT GarmentVistar Medical Supplies Co., Ltd. · 2026
  • K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K944567 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944567: Cowboy X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944567

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026