510(k) Report

510(k) · Cleared

Cleared

Activecare DVT, Activecare+SFT, and Activecare+DTX Systems

K140755510(k) SpecialCleared May 8, 201443-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 8, 2014 as substantially equivalent to K113525 (Medical Compression Systems (Dbn), Ltd., 2012) and 1 other predicate after a 43-day review. Its family tree reaches back 5 generations to 1995. 7 later devices descend from it.

Decided
May 8, 2014
Review
43 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K944567 (1995). 12 ancestors in all, the oldest K915092 (1992). 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2002: 2 other ancestors2000: 1 other ancestor1995: 1 other ancestor1992: 2 other ancestors2021: 1 descendant cleared2014: 1 descendant 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 · recalledK110159 · Activecare SFT · Medical Compression Systems (Dbn), Ltd. · 20111990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K110159 · Activecare SFT · Medical Compression Systems (Dbn), Ltd. · 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 backK110159 Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
  6. This deviceK140755 Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd. · 2014
  7. Descendant · cites it directly · 2 of its ownK162481 RF1400 Active Compression WrapRecovery Force, LLC · 2017
  8. Descendant · cites it directly · 2 of its ownK142728 ActiveCare+SFT; ActiveCare+SFT HomeCare…Medical Compressions System (Dbn), Ltd. · 2014
  9. Descendant · 2 generations on · 1 of its ownK232300 ElastiMed SACSElastimed, Ltd. · 2023
  10. Descendant · 2 generations on · 1 of its ownK151377 ActiveCare+SFT;ActiveCare+SFT HomeCare…Medical Compression System (Dbn), Ltd. · 2015
  11. Descendant · 3 generations on · 0 of its ownK243177 Sacs ProElastimed, Ltd. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12016: 12017: 12021: 12023: 12024: 1
2014high 1 (2014) · low 0 (2018)2026

Most influential descendants

Showing 5 of 7 · See all
  • K162481RF1400 Active Compression WrapRecovery Force, LLC · 2017 · cites it directly2descendants
  • K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd. · 2014 · cites it directly2descendants
  • K232300ElastiMed SACSElastimed, Ltd. · 2023 · 2 generations on1descendant
  • K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd. · 2015 · 2 generations on1descendant
  • K243177Sacs ProElastimed, Ltd. · 2024 · 3 generations on0descendants
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
−1K110159Activecare SFTMedical Compression Systems (Dbn), Ltd.2011—
0 (this device)K140755Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd.2014—
+1K162481RF1400 Active Compression WrapRecovery Force, LLC2017—
+1K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category)…Medical Compressions System (Dbn), Ltd.2014—
+2K232300ElastiMed SACSElastimed, Ltd.2023—
+2K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd.2015—
+3K243177Sacs ProElastimed, Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199510
200010
200220
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201610
201710
202110
202310
202410
FIG. 1 — Lineage of K140755, 1995–2024Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K113525Activecare DVT Activecare+SFT
Summary page 2
…scular Devices Predicate Devices Medical Compression Systems (DBN) Ltd. ActiveCare DVT (K(1 13525) Medical Compression Systems (DBN) Ltd. ActiveCare+SFT(K1 13525) Medical Compression Systems (DBN) Ltd. ActiveCare+DTx (KI 10159) Purpose of the Special 510(k) notice This special 510(k).was…
Medical Compression Systems (Dbn), Ltd.2012—
*K110159Activecare SFTMedical Compression Systems (Dbn), Ltd.2011—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K162481RF1400 Active Compression WrapRecovery Force, LLC20172
K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd.20142
K203052Movement and Compressions System (the MAC System)Recovery Force, LLC20210

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 19 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
  • 3 of the 12 ancestors have a recall of any class.
  • Of its descendants, K162481 (Recovery Force, LLC, 2017) has gone furthest, with 2 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. 2014, 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 DVT, ActiveCare.SFT and ActiveCare+DTx Systems are prescriptive devices that induce Continuous Enhanced Circulation Therapy of the lower limbs.

The Systems are intended for use in:

Preventing Deep Vein Thrombosis (DVT).

Enhancing blood ciculation.

Diminishing post-operative pain and swelling.

Reducing wound-healing time.

Treatment and assistance inhealing: stasis dermatitis; venious 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 Medical Compression Systems (Dbn), Ltd.

10 FDA decisions under this applicant name. See the company

  • K160431ActiveCare HomeMedical Compression Systems (Dbn), Ltd. · 2016
  • K113525Activecare DVT Activecare+SFTMedical Compression Systems (Dbn), Ltd. · 2012
  • K110159Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
  • 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/K140755 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140755: Activecare DVT, Activecare+SFT, and Activecare+DTX Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140755

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026