510(k) · Cleared
ClearedFlexitouch® Plus Advanced Pneumatic Compression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tactile Medical · JOW Sleeve, Limb, Compressible
Cleared on Jul 31, 2026 as substantially equivalent to K203178 (Tactile Systems Technology, Inc. (Dba Tactile Medical), 2020) and 1 other predicate after a 259-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Jul 31, 2026
- Review
- 259 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K944567 (1995). 22 ancestors in all, the oldest K914774 (1992). No later device cites it as a predicate yet.
- Root · 11 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 7 generations between
- 3 generations backK193288 Koya RippleKoya, Inc. · 2020
- 2 generations backK210885 DayspringKoya Medical, Inc. · 2021
- 1 generation backK223228 DayspringKoya Medical, Inc. · 2024
- This deviceK253555 Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
Show all 11 generations
- Root · 11 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 10 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 9 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 8 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- 7 generations backK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
- 6 generations backK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
- 5 generations backK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016
- 4 generations backK170216 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017
- 3 generations backK193288 Koya RippleKoya, Inc. · 2020
- 2 generations backK210885 DayspringKoya Medical, Inc. · 2021
- 1 generation backK223228 DayspringKoya Medical, Inc. · 2024
- This deviceK253555 Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −10 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −9 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −8 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| −7 | K062818 | Flexitouch System | Tactile Systems Technology, Inc. | 2006 | — |
| −6 | K120972 | Flexitouch System | Tactile Systems Technology, Inc. | 2012 | — |
| −5 | K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016 | — |
| −4 | K170216 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2017 | — |
| −3 | K193288 | Koya Ripple | Koya, Inc. | 2020 | — |
| −2 | K210885 | Dayspring | Koya Medical, Inc. | 2021 | — |
| −1 | K223228 | Dayspring | Koya Medical, Inc. | 2024 | — |
| 0 (this device) | 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 |
| 2019 | 1 | 0 |
| 2020 | 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 K254217 Aerloomscore 13.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203178 | Flexitouch Plus SystemSummary page 5…Product Codes: JOW PPS Predicate Devices: Primary: Flexitouch® Plus Advanced Pneumatic Compression System (K203178) Additional: Dayspring (K223228) Device Description The Flexitouch Plus system is an advanced pneumatic… | 2020 |
| * | K223228 | DayspringSummary page 5…PPS Predicate Devices: Primary: Flexitouch® Plus Advanced Pneumatic Compression System (K203178) Additional: Dayspring (K223228) Device Description The Flexitouch Plus system is an advanced pneumatic compression device to stimulate the lymphatic system.… | 2024 |
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 31 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 22 ancestors have a recall of any class.
- 2 other devices also cite its predicate K203178.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions, such as: ■ Lymphedema ■ Primary lymphedema ■ Post-mastectomy edema ■ Edema following trauma and sports injuries ■ Post-immobilization edema ■ Venous insufficiency ■ Reduction in wound healing time ■ Treatment and assistance in…
Read the full statement (120 words)
The Flexitouch Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions, such as:
■ Lymphedema
■ Primary lymphedema
■ Post-mastectomy edema
■ Edema following trauma and sports injuries
■ Post-immobilization edema
■ Venous insufficiency
■ Reduction in wound healing time
■ Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial ulcers and diabetic leg ulcers
■ Lipedema
■ Phlebolymphedema
The Flexitouch Plus 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/K253555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253555: Flexitouch® Plus Advanced Pneumatic Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253555
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026