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. (Dba Tactile Medical) · JOW Sleeve, Limb, Compressible
Cleared on May 26, 2017 as substantially equivalent to K153311 (Tactile Systems Technology, Inc. (Dba Tactile Medical), 2016) after a 122-day review. Its family tree reaches back 7 generations to 1995. 7 later devices descend from it.
- Decided
- May 26, 2017
- Review
- 122 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K944567 (1995). 16 ancestors in all, the oldest K914774 (1992). 7 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 6 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 5 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 4 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- 3 generations backK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
- 2 generations backK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
- 1 generation backK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016
- This deviceK170216 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017
- Descendant · cites it directly · 5 of its ownK203178 Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2020
- Descendant · cites it directly · 5 of its ownK193288 Koya RippleKoya, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK210885 DayspringKoya Medical, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK223228 DayspringKoya Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253555 Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K203178Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2020 · cites it directly5descendants
- K193288Koya RippleKoya, Inc. · 2020 · cites it directly5descendants
- K210885DayspringKoya Medical, Inc. · 2021 · 2 generations on4descendants
- K223228DayspringKoya Medical, Inc. · 2024 · 2 generations on1descendant
- K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −6 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −5 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −4 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| −3 | K062818 | Flexitouch System | Tactile Systems Technology, Inc. | 2006 | — |
| −2 | K120972 | Flexitouch System | Tactile Systems Technology, Inc. | 2012 | — |
| −1 | K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016 | — |
| 0 (this device) | K170216 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2017 | — |
| +1 | K203178 | Flexitouch Plus System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2020 | — |
| +1 | K193288 | Koya Ripple | Koya, Inc. | 2020 | — |
| +2 | K210885 | Dayspring | Koya Medical, Inc. | 2021 | — |
| +2 | K223228 | Dayspring | Koya Medical, Inc. | 2024 | — |
| +2 | K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K153311 | Flexitouch SystemSummary page 4…Sleeve, Head, and Neck, Compressible (21 CFR 870.5800) Product Code(s): JOW, PPS Predicate Device: Tactile Systems Technology, Inc. Flexitouch® System (K153311) Reference Device: Entré PD08-U (K143185) Description of Device: The Flexitouch ®system consists of two main components… | 2016 |
| † | K143185 | entré Model PD08-U | 2015 |
What descends from it? (7)
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 22 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K203178 (Tactile Systems Technology, Inc. (Dba Tactile Medical), 2020) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Flexitouch System and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: • Lymphedema • Primary lymphedema • Post mastectomy edema • Edema following trauma and sports injuries • Post immobilization edema • Venous insufficiency • Reducing wound healing time • Treatment and assistance in healing stasis dermatitis, venous…
Read the full statement (110 words)
The Flexitouch System and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as:
• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• Edema following trauma and sports injuries
• Post immobilization edema
• Venous insufficiency
• Reducing wound healing time
• Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
The Flexitouch System and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170216 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170216: Flexitouch System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170216
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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