510(k) · Cleared
Recalled · 2011Activecare ++ System
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 Mar 8, 2006 as substantially equivalent to K023573 (Medical Compression Systems (Dbn), Ltd., 2002) and 3 other predicates after a 48-day review. Its family tree reaches back 3 generations to 1995. 30 later devices descend from it. It has been recalled once.
- Decided
- Mar 8, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- JOW
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K944567 (1995). 9 ancestors in all, the oldest K915092 (1992). 30 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 2 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 1 generation backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- This deviceK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006
- Descendant · cites it directly · 10 of its ownK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK110159 Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
- Descendant · 2 generations on · 8 of its ownK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016
- Descendant · cites it directly · 8 of its ownK113525 Activecare DVT Activecare+SFTMedical Compression Systems (Dbn), Ltd. · 2012
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K062818Flexitouch SystemTactile Systems Technology, Inc. · 2006 · cites it directly10descendants
- K120972Flexitouch SystemTactile Systems Technology, Inc. · 2012 · 2 generations on9descendants
- K110159Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011 · cites it directly9descendants
- K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016 · 2 generations on8descendants
- K113525Activecare DVT Activecare+SFTMedical Compression Systems (Dbn), Ltd. · 2012 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −2 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −1 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| 0 (this device) | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | — |
| +1 | K062818 | Flexitouch System | Tactile Systems Technology, Inc. | 2006 | — |
| +2 | K120972 | Flexitouch System | Tactile Systems Technology, Inc. | 2012 | — |
| +1 | K110159 | Activecare SFT | Medical Compression Systems (Dbn), Ltd. | 2011 | — |
| +2 | K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016 | — |
| +1 | K113525 | Activecare DVT Activecare+SFT | Medical Compression Systems (Dbn), Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2026 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K023573 | Wizair Compression SystemSummary page 1…veCare® Syvm,,~ 3000), previously named WizAir Compression System, Wizair DVT or ProAir cleared under K023573, K(012994, K002287 and K993758. 7-4 7.1.8 Device Description: The Active… | 2002 |
| * | K012994 | Wizair DVTSummary page 3…able Medical Compression Systems (DBN) Ltd.'s Systems (ActiveCare® System, previously named WizAir Compression System, Wizair DVT or ProAir 3000), cleared under K023573, K012994, K002287 and K993758. The principle changes between the devices include: * The software programming language was changed from A… | 2002 |
| * | K002287 | Wizair Compression SystemSummary page 1…3000), previously named WizAir Compression System, Wizair DVT or ProAir cleared under K023573, K(012994, K002287 and K993758. 7-4 7.1.8 Device Description: The ActiveCare®++ is a prescr… | 2000 |
| * | K993758 | Proair 3000 Compression SystemSummary page 1…3000), previously named WizAir Compression System, Wizair DVT or ProAir cleared under K023573, K(012994, K002287 and K993758. 7-4 7.1.8 Device Description: The ActiveCare®++ is a prescriptive, pneu… | 2000 |
What descends from it? (30)
See all 306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062818 | Flexitouch System | 2006 | 10 |
| K110159 | Activecare SFT | 2011 | 9 |
| K113525 | Activecare DVT Activecare+SFT | 2012 | 8 |
| K103113 | Vasculaire Compression System | 2011 | 4 |
| K122609 | Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model… | 2012 | 3 |
| K073028 | Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30 | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2011 | Not classified | Z-0386-2012 | Device Design | This voluntary field action is being undertaken because MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K062818 (Tactile Systems Technology, Inc., 2006) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K023573.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The ActiveCare®++ 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.
https://510kreport.com/device/K060146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060146: Activecare ++ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060146
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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