510(k) Report

510(k) · Cleared

Cleared

Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model FLS-0002; Vasculaire Sleeve (Calf) F

K122609510(k) TraditionalCleared Dec 21, 2012116-day reviewClass II21 CFR 870.5800

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

Venous Health Systems, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Dec 21, 2012 as substantially equivalent to K103113 (Venous Health Systems, Inc., 2011) and 4 other predicates after a 116-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.

Decided
Dec 21, 2012
Review
116 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K944567 (1995). 11 ancestors in all, the oldest K915092 (1992). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors2000: 1 other ancestor1995: 1 other ancestor1992: 2 other ancestors2018: 1 descendant cleared2013: 1 descendant cleared2019: 1 descendant clearedK944567 · Cowboy X · Kinetic Concepts, Inc. · 1995 · recalledK981311 · Cowboy XV · Kci New Technologies, Inc. · 1999K993758 · Proair 3000 Compression System · Medical Compression Systems (Dbn), Ltd. · 2000K060146 · Activecare ++ System · Medical Compression Systems (Dbn), Ltd. · 2006 · recalledK103113 · Vasculaire Compression System · Venous Health Systems, Inc. · 20111990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K103113 · Vasculaire Compression System · Venous Health Systems, Inc. · 2011K060146 · Activecare ++ System · Medical Compression Systems (Dbn), Ltd. · 2006 · recalledK993758 · Proair 3000 Compression System · Medical Compression Systems (Dbn), Ltd. · 2000K981311 · Cowboy XV · Kci New Technologies, Inc. · 1999K944567 · Cowboy X · Kinetic Concepts, Inc. · 1995 · recalled−50
  1. Root · 5 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
  2. 4 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
  3. 3 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
  4. 2 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
  5. 1 generation backK103113 Vasculaire Compression SystemVenous Health Systems, Inc. · 2011
  6. This deviceK122609 Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve…Venous Health Systems, Inc. · 2012
  7. Descendant · cites it directly · 1 of its ownK181651 Radial Medical Compression SystemRadial Medical, Inc. · 2018
  8. Descendant · 2 generations on · 0 of its ownK190976 Radial Medical Compression SystemRadial Medical, Inc. · 2019
  9. Descendant · cites it directly · 0 of its ownK131046 Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf)…Venous Health Systems, Inc. · 2013

Most influential descendants

Showing 3 of 3 · See all
  • K181651Radial Medical Compression SystemRadial Medical, Inc. · 2018 · cites it directly1descendant
  • K190976Radial Medical Compression SystemRadial Medical, Inc. · 2019 · 2 generations on0descendants
  • K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)Venous Health Systems, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K944567Cowboy XKinetic Concepts, Inc.19951
−4K981311Cowboy XVKci New Technologies, Inc.1999—
−3K993758Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd.2000—
−2K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd.20061
−1K103113Vasculaire Compression SystemVenous Health Systems, Inc.2011—
0 (this device)K122609Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf)…Venous Health Systems, Inc.2012—
+1K181651Radial Medical Compression SystemRadial Medical, Inc.2018—
+2K190976Radial Medical Compression SystemRadial Medical, Inc.2019—
+1K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire…Venous Health Systems, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199510
200010
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201810
201910
FIG. 1 — Lineage of K122609, 1995–2019Source: 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), 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. #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
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What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K103113Vasculaire Compression System
Summary page 2
…Traditional 510(k): Summary 510(k) SUMMARY (Cant.) PREDICATE DEVICE(S) Venous Health Systems, Inc., Vascula ire Compression System (K103113) Medical Compression Systems (MCS), WizAir DVT Tm (K012994) Medical Compression Systems (MCS), ActiveCare++ ®System (K060146)…
Venous Health Systems, Inc.2011—
*K012994Wizair DVT
Summary page 2
…510(k) SUMMARY (Cant.) PREDICATE DEVICE(S) Venous Health Systems, Inc., Vascula ire Compression System (K103113) Medical Compression Systems (MCS), WizAir DVT Tm (K012994) Medical Compression Systems (MCS), ActiveCare++ ®System (K060146) Kinetic Concepts Inc. (KCI), Plexipulse All-in-1i® System…
Medical Compression Systems (Dbn), Ltd.2002—
*K060146Activecare ++ System
Summary page 2
…s, Inc., Vascula ire Compression System (K103113) Medical Compression Systems (MCS), WizAir DVT Tm (K012994) Medical Compression Systems (MCS), ActiveCare++ ®System (K060146) Kinetic Concepts Inc. (KCI), Plexipulse All-in-1i® System (K944567/K981311) INDICATIONS FOR USE The Vasculaire Compressio…
Medical Compression Systems (Dbn), Ltd.20061
*K944567Cowboy X
Summary page 2
…n Systems (MCS), WizAir DVT Tm (K012994) Medical Compression Systems (MCS), ActiveCare++ ®System (K060146) Kinetic Concepts Inc. (KCI), Plexipulse All-in-1i® System (K944567/K981311) INDICATIONS FOR USE The Vasculaire Compression System is indicated for use in: * Preventing deep vein thrombos…
Kinetic Concepts, Inc.19951
*K981311Cowboy XV
Summary page 2
…s (MCS), WizAir DVT Tm (K012994) Medical Compression Systems (MCS), ActiveCare++ ®System (K060146) Kinetic Concepts Inc. (KCI), Plexipulse All-in-1i® System (K944567/K981311) INDICATIONS FOR USE The Vasculaire Compression System is indicated for use in: * Preventing deep vein thrombosis (DVT)…
Kci New Technologies, Inc.1999—

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K181651Radial Medical Compression SystemRadial Medical, Inc.20181
K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)Venous Health Systems, Inc.20130

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 17 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
  • 3 of the 11 ancestors have a recall of any class.
  • Of its descendants, K181651 (Radial Medical, Inc., 2018) has gone furthest, with 1 descendant 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. 2012, this device’s year, is highlighted.

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—

What is it indicated for?

The Vasculaire Compression System is indicated for use in:

* Preventing deep vein thrombosis (DVT)

* Enhancing blood circulation

* Diminishing post-operative pain and swelling

* Reducing wound healing time

* Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers

* Treatment of chronic venous insufficiency

* Reducing edema

Indications for use as stated in the FDA summary.

More from Venous Health Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)Venous Health Systems, Inc. · 2013
  • K103113Vasculaire Compression SystemVenous Health Systems, Inc. · 2011

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/K122609 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122609: Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model FLS-0002; Vasculaire Sleeve (Calf) F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122609

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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