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) · PPS Sleeve, Head And Neck, Compressible
Cleared on Sep 14, 2016 as substantially equivalent to K120972 (Tactile Systems Technology, Inc., 2012) and 2 other predicates after a 302-day review. Its family tree reaches back 6 generations to 1995. 8 later devices descend from it.
- Decided
- Sep 14, 2016
- Review
- 302 days
- Class
- Class II
- Product code
- PPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K944567 (1995). 15 ancestors in all, the oldest K914774 (1992). 8 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 5 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 4 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 3 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- 2 generations backK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
- 1 generation backK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
- This deviceK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016
- Descendant · cites it directly · 7 of its ownK170216 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017
- Descendant · 2 generations on · 5 of its ownK203178 Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2020
- Descendant · 2 generations on · 5 of its ownK193288 Koya RippleKoya, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK210885 DayspringKoya Medical, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK223228 DayspringKoya Medical, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K170216Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017 · cites it directly7descendants
- K203178Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2020 · 2 generations on5descendants
- K193288Koya RippleKoya, Inc. · 2020 · 2 generations on5descendants
- K210885DayspringKoya Medical, Inc. · 2021 · 3 generations on4descendants
- K223228DayspringKoya Medical, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −5 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −4 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −3 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| −2 | K062818 | Flexitouch System | Tactile Systems Technology, Inc. | 2006 | — |
| −1 | K120972 | Flexitouch System | Tactile Systems Technology, Inc. | 2012 | — |
| 0 (this device) | K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016 | — |
| +1 | K170216 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2017 | — |
| +2 | K203178 | Flexitouch Plus System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2020 | — |
| +2 | K193288 | Koya Ripple | Koya, Inc. | 2020 | — |
| +3 | K210885 | Dayspring | Koya Medical, Inc. | 2021 | — |
| +3 | K223228 | Dayspring | Koya Medical, Inc. | 2024 | — |
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 |
|---|---|---|
| 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 PPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K120972 | Flexitouch SystemSummary page 4…Sleeve, Head and Neck, Compressible (21 CFR 870.5800) Device Classification: Class II Predicate Device: Tactile Systems Technology, Inc. Flexitouch® system (K120972, K062818 & K013061) Description of Device The Flexitouch® system consists of two main components: a gar… | 2012 |
| * | K062818 | Flexitouch SystemSummary page 4…essible (21 CFR 870.5800) Device Classification: Class II Predicate Device: Tactile Systems Technology, Inc. Flexitouch® system (K120972, K062818 & K013061) Description of Device The Flexitouch® system consists of two main components: a garment set and a pneumatic sequenti… | 2006 |
| * | K013061 | Biotouch Massage Therapy SystemSummary page 4…1 CFR 870.5800) Device Classification: Class II Predicate Device: Tactile Systems Technology, Inc. Flexitouch® system (K120972, K062818 & K013061) Description of Device The Flexitouch® system consists of two main components: a garment set and a pneumatic sequential control… | 2002 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170216 | Flexitouch System | 2017 | 7 |
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 4.4 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K170216 (Tactile Systems Technology, Inc. (Dba Tactile Medical), 2017) has gone furthest, with 7 descendants of its own.
How does its category compare?
All PPS devicesPPS Sleeve, Head And Neck, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PPS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · PPS
Too few PPS 510(k)s in any year since 2007 to give a median.
Recalls per year · PPS
No recall names PPS since 2007.
Adverse event reports per year · PPS
No MAUDE report names PPS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 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 insufficiencies • 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 insufficiencies
• 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/K153311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153311: Flexitouch System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153311
Report an extraction error
Are you the manufacturer?
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