510(k) · Cleared
ClearedFlexitouch System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tactile Systems Technology, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Oct 6, 2006 as substantially equivalent to K043423 (Bio Compression Systems, Inc., 2005) and 2 other predicates after a 16-day review. Its family tree reaches back 4 generations to 1995. 10 later devices descend from it.
- Decided
- Oct 6, 2006
- Review
- 16 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K944567 (1995). 13 ancestors in all, the oldest K914774 (1992). 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 3 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 2 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 1 generation backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- This deviceK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016
- Descendant · 2 generations on · 7 of its ownK170216 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017
- Descendant · 3 generations on · 5 of its ownK203178 Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2020
- Descendant · 3 generations on · 5 of its ownK193288 Koya RippleKoya, Inc. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K120972Flexitouch SystemTactile Systems Technology, Inc. · 2012 · cites it directly9descendants
- K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016 · cites it directly8descendants
- K170216Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017 · 2 generations on7descendants
- K203178Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2020 · 3 generations on5descendants
- K193288Koya RippleKoya, Inc. · 2020 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −3 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −2 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −1 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| 0 (this device) | K062818 | Flexitouch System | Tactile Systems Technology, Inc. | 2006 | — |
| +1 | K120972 | Flexitouch System | Tactile Systems Technology, Inc. | 2012 | — |
| +1 | K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016 | — |
| +2 | K170216 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2017 | — |
| +3 | K203178 | Flexitouch Plus System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2020 | — |
| +3 | K193288 | Koya Ripple | Koya, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K043423 | Model SC-3008 Sequential CirculatorSummary page 1…tion: Powered Inflatable Tube Massager, Class II Predicate Devices: Bio Compression Systems, Inc. Model SC-3008 Sequential Circulator (K043423) Medical Compression Systems Ltd ActiveCare®++ System (K060146)… | 2005 |
| * | K060146 | Activecare ++ SystemSummary page 1…Model SC-3008 Sequential Circulator (K043423) Medical Compression Systems Ltd ActiveCare®++ System (K060146) Tactile Systems Technology, Inc. Flexitouch® System (K013061) Description of Device: The Flexitouch® Sy… | 2006 |
| * | K013061 | Biotouch Massage Therapy SystemSummary page 1…Medical Compression Systems Ltd ActiveCare®++ System (K060146) Tactile Systems Technology, Inc. Flexitouch® System (K013061) Description of Device: The Flexitouch® System is a powered inflatable tube massager intended for medical purposes. The primary… | 2002 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K120972 (Tactile Systems Technology, Inc., 2012) has gone furthest, with 9 descendants of its own.
- 8 other devices also cite its predicate K043423.
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 Flexitouch system is intended for use by medical professionals and patients who are under medical supervision, in treating many conditions such as:
• Primary lymphedema
* Post mastectomy edema
* Edema following trauma and sports injuries
* Post immobilization edema
* Venous insufficiencies
* Lymphedema.
* Reducing wound healing time
* Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062818 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062818: Flexitouch System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062818
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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