510(k) · Cleared
ClearedTherm-X Pro, Therm-X AT, Therm-X Pro Athlete
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zenith Technical Innovations · IRP Massager, Powered Inflatable Tube
Cleared on Aug 3, 2018 as substantially equivalent to K171685 (Cool Systems, Inc. (Dba Game Ready), 2017) and 3 other predicates after a 94-day review. Its family tree reaches back 4 generations to 1988. 12 later devices descend from it.
- Decided
- Aug 3, 2018
- Review
- 94 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K881632 (1988). 23 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
- 3 generations backK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
- 2 generations backK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
- 1 generation backK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
- This deviceK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- Descendant · cites it directly · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019
- Descendant · cites it directly · 10 of its ownK193550 Therm-XZenith Technical Innovations · 2020
- Descendant · 2 generations on · 3 of its ownK223729 FLOWpressoMedella Health Limited · 2023
- Descendant · 3 generations on · 2 of its ownK232965 Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK223541 Cold/Hot CompressionJkh Health Co., Ltd. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K190854Therm-XZenith Technical Innovations · 2019 · cites it directly11descendants
- K193550Therm-XZenith Technical Innovations · 2020 · cites it directly10descendants
- K223729FLOWpressoMedella Health Limited · 2023 · 2 generations on3descendants
- K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)Shenzhen Ruiyi Business Technology Co., Ltd. · 2024 · 3 generations on2descendants
- K223541Cold/Hot CompressionJkh Health Co., Ltd. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881632 | Flowtron DVT System AC500 Pump, L501 Garment | Huntleigh Technology, Inc. | 1988 | — |
| −3 | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | Bio Compression Systems, Inc. | 2006 | — |
| −2 | K072666 | Bioarterial Plus, Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2007 | — |
| −1 | K131327 | Bioarterial Plus Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2013 | — |
| 0 (this device) | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| +1 | K190854 | Therm-X | Zenith Technical Innovations | 2019 | — |
| +1 | K193550 | Therm-X | Zenith Technical Innovations | 2020 | — |
| +2 | K223729 | FLOWpresso | Medella Health Limited | 2023 | — |
| +3 | K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | Shenzhen Ruiyi Business Technology Co., Ltd. | 2024 | — |
| +2 | K223541 | Cold/Hot Compression | Jkh Health Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 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 IRP? 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 IRP device
- #1 K193354 Air Compression Therapy Devicescore 28.6 · 8 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 |
|---|---|---|---|
| * | K171685 | Med4 EliteSummary page 5…Systems, Inc K181149 Zenith RTA Response Amendment Page 4-1 of 4-28 510(k) K171685 K061866 K072620 K131327 Number: Classification: Class II Class II Class II Cla… | 2017 |
| * | K061866 | Nanotherm, Vascutherm and Prothermo Therapy WrapsSummary page 5…Systems, Inc K181149 Zenith RTA Response Amendment Page 4-1 of 4-28 510(k) K171685 K061866 K072620 K131327 Number: Classification: Class II Class II Class II Class II Regulatio… | 2006 |
| * | K072620 | Game Ready Classic System, Model 550550Summary page 5…, Inc K181149 Zenith RTA Response Amendment Page 4-1 of 4-28 510(k) K171685 K061866 K072620 K131327 Number: Classification: Class II Class II Class II Class II Regulation 890.56… | 2007 |
| * | K131327 | Bioarterial Plus Arterial Blood Flow Enhancement SystemSummary page 5…Zenith RTA Response Amendment Page 4-1 of 4-28 510(k) K171685 K061866 K072620 K131327 Number: Classification: Class II Class II Class II Class II Regulation 890.5650, 870.5800… | 2013 |
What descends from it? (12)
See all 122 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 30 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K190854 (Zenith Technical Innovations, 2019) has gone furthest, with 11 descendants of its own.
- 7 other devices also cite its predicate K171685.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · IRP
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRP
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IRP
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IRP
10in 2025
MAUDE reports naming product code IRP, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 5 |
| 2011 | 3 | 164 | 1 | 3 |
| 2012 | 5 | 116 | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 113 | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 4 | 170 | 2 | 0 |
| 2018 | 3 | 80 | 0 | 0 |
| 2019 | 10 | 83 | 0 | 0 |
| 2020 | 9 | 150 | 0 | 1 |
| 2021 | 19 | 140 | 0 | 0 |
| 2022 | 14 | 97 | 0 | 1 |
| 2023 | 10 | 143 | 0 | 0 |
| 2024 | 12 | 115 | 0 | 4 |
| 2025 | 13 | 141 | 0 | 10 |
| 2026 | 12 | 172 | 0 | — |
What is it indicated for?
Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. Therm-X Pro and Therm-X Pro Athlete…
Read the full statement (140 words)
Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.
Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro and Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.
Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181149
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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