510(k) Report

510(k) · Cleared

Cleared

Activecare SFT

K110159510(k) TraditionalCleared May 12, 2011113-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

Medical Compression Systems (Dbn), Ltd. · JOW Sleeve, Limb, Compressible

Cleared on May 12, 2011 as substantially equivalent to K060146 (Medical Compression Systems (Dbn), Ltd., 2006) after a 113-day review. Its family tree reaches back 4 generations to 1995. 9 later devices descend from it.

Decided
May 12, 2011
Review
113 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K944567 (1995). 10 ancestors in all, the oldest K915092 (1992). 9 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 ancestors2021: 2 descendants cleared2014: 2 descendants cleared2017: 1 descendant cleared2015: 1 descendant cleared2023: 1 descendant cleared2016: 1 descendant cleared2024: 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants K060146 · 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 · recalled0
  1. Root · 4 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
  2. 3 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
  3. 2 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
  4. 1 generation backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
  5. This deviceK110159 Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
  6. Descendant · cites it directly · 7 of its ownK140755 Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd. · 2014
  7. Descendant · 2 generations on · 2 of its ownK162481 RF1400 Active Compression WrapRecovery Force, LLC · 2017
  8. Descendant · 2 generations on · 2 of its ownK142728 ActiveCare+SFT; ActiveCare+SFT HomeCare…Medical Compressions System (Dbn), Ltd. · 2014
  9. Descendant · 3 generations on · 1 of its ownK232300 ElastiMed SACSElastimed, Ltd. · 2023
  10. Descendant · 3 generations on · 1 of its ownK151377 ActiveCare+SFT;ActiveCare+SFT HomeCare…Medical Compression System (Dbn), Ltd. · 2015

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014: 22015: 12016: 12017: 12021: 22023: 12024: 1
2014high 2 (2014) · low 0 (2018)2026

Most influential descendants

Showing 5 of 9 · See all
  • K140755Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd. · 2014 · cites it directly7descendants
  • K162481RF1400 Active Compression WrapRecovery Force, LLC · 2017 · 2 generations on2descendants
  • K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd. · 2014 · 2 generations on2descendants
  • K232300ElastiMed SACSElastimed, Ltd. · 2023 · 3 generations on1descendant
  • K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd. · 2015 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K944567Cowboy XKinetic Concepts, Inc.19951
−3K981311Cowboy XVKci New Technologies, Inc.1999—
−2K993758Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd.2000—
−1K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd.20061
0 (this device)K110159Activecare SFTMedical Compression Systems (Dbn), Ltd.2011—
+1K140755Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd.2014—
+2K162481RF1400 Active Compression WrapRecovery Force, LLC2017—
+2K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category)…Medical Compressions System (Dbn), Ltd.2014—
+3K232300ElastiMed SACSElastimed, Ltd.2023—
+3K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd.2015—

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
201420
201510
201610
201710
202120
202310
202410
FIG. 1 — Lineage of K110159, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K060146Activecare ++ System
Summary page 1
…Panel: Cardiovascular Devices 7.1.7 Predicate Devices Medical Compression Systems (DBN) Ltd. ActiveCare+SFT® System, previously cleared as ActiveCare®)++ under K060146. 7-4 7.1.8 Device Description: The ActiveCare+SFT® is a prescriptive,…
Medical Compression Systems (Dbn), Ltd.20061

Also cleared against K060146: 5 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K140755Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd.20147
K211200WoundExpressHuntleigh Healthcare, Ltd.20210

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 16 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
  • 3 of the 10 ancestors have a recall of any class.
  • Of its descendants, K140755 (Medical Compression Systems (Dbn), Ltd., 2014) has gone furthest, with 7 descendants of its own.
  • 5 other devices also cite its predicate K060146.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The ActiveCare+SFT® System is intended 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.

Also cleared against K060146

5 other devices cite the same predicate.

  • K122609Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model FLS-0002; Vasculaire…Venous Health Systems, Inc. · 2012
  • K113525Activecare DVT Activecare+SFTMedical Compression Systems (Dbn), Ltd. · 2012
  • K103113Vasculaire Compression SystemVenous Health Systems, Inc. · 2011
  • K073028Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30Venowave, Inc. · 2008
  • K062818Flexitouch SystemTactile Systems Technology, Inc. · 2006

More from Medical Compression Systems (Dbn), Ltd.

10 FDA decisions under this applicant name. See the company

  • K160431ActiveCare HomeMedical Compression Systems (Dbn), Ltd. · 2016
  • K140755Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd. · 2014
  • K113525Activecare DVT Activecare+SFTMedical Compression Systems (Dbn), Ltd. · 2012
  • K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 20061 recall
  • K023573Wizair Compression SystemMedical Compression Systems (Dbn), Ltd. · 20021 recall

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/K110159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110159: Activecare SFT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110159

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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