510(k) · Cleared
ClearedActiveCare Home
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Compression Systems (Dbn), Ltd. · JOW Sleeve, Limb, Compressible
Cleared on Jul 13, 2016 as substantially equivalent to K151377 (Medical Compression System (Dbn), Ltd., 2015) after a 148-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Jul 13, 2016
- Review
- 148 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K944567 (1995). 32 ancestors in all, the oldest K915638 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 7 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 6 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 5 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- 4 generations backK110159 Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
- 3 generations backK140755 Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd. · 2014
- 2 generations backK142728 ActiveCare+SFT; ActiveCare+SFT HomeCare…Medical Compressions System (Dbn), Ltd. · 2014
- 1 generation backK151377 ActiveCare+SFT;ActiveCare+SFT HomeCare…Medical Compression System (Dbn), Ltd. · 2015
- This deviceK160431 ActiveCare HomeMedical Compression Systems (Dbn), Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −7 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −6 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −5 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| −4 | K110159 | Activecare SFT | Medical Compression Systems (Dbn), Ltd. | 2011 | — |
| −3 | K140755 | Activecare DVT, Activecare+SFT, and Activecare+DTX Systems | Medical Compression Systems (Dbn), Ltd. | 2014 | — |
| −2 | K142728 | ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category)… | Medical Compressions System (Dbn), Ltd. | 2014 | — |
| −1 | K151377 | ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare | Medical Compression System (Dbn), Ltd. | 2015 | — |
| 0 (this device) | K160431 | ActiveCare Home | Medical Compression Systems (Dbn), Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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 |
|---|---|---|---|
| * | K151377 | ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareSummary page 4…II Panel: Cardiovascular III. PREDICATE DEVICE The predicate device is the ActiveCare@Home, cleared under K151377. IV. DEVICE DESCRIPTION The ActiveCare Systems are portable, ambulatory, sequential, intermittent pneumatic co… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 32 ancestors have a recall of any class.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 ActiveCare+SFT®and ActiveCare+DTx® Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the…
Read the full statement (227 words)
The ActiveCare+SFT®and ActiveCare+DTx® Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopaedic surgery procedures e.g. total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment and can be provided directly to the patient for home use.
These devices are indicated for use in:
* Preventing Deep Vein Thrombosis (DVT)
* Diminishing post-operative pain and swelling
* Reducing wound healing time
* Patients at risk for Deep Vein Thrombosis (DVT) and related Pulmonary Embolism (PE) (Venous Thromboembolism (VTE))
* Treatment of venous stasis
Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
* Enhancing blood circulation
* Treatment of chronic venous insufficiency
* Reducing edema
The ActiveCare+SFT® and ActiveCare+DTx® Systems are intended to provide external compression in synchrony with the specific patient’s natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx® System can detect hemodynamic changes in venous blood flow.
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/K160431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160431: ActiveCare Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160431
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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