510(k) · Cleared
ClearedTherm-X
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 May 10, 2019 as substantially equivalent to K181149 (Zenith Technical Innovations, 2018) and 2 other predicates after a 38-day review. Its family tree reaches back 5 generations to 1988. 11 later devices descend from it.
- Decided
- May 10, 2019
- Review
- 38 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K881632 (1988). 24 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
- 4 generations backK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
- 3 generations backK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
- 2 generations backK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
- 1 generation backK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- This deviceK190854 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
- Descendant · 2 generations on · 1 of its ownK231912 Therm-XZenith Technical Innovations · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- 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
- K231912Therm-XZenith Technical Innovations · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881632 | Flowtron DVT System AC500 Pump, L501 Garment | Huntleigh Technology, Inc. | 1988 | — |
| −4 | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | Bio Compression Systems, Inc. | 2006 | — |
| −3 | K072666 | Bioarterial Plus, Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2007 | — |
| −2 | K131327 | Bioarterial Plus Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2013 | — |
| −1 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| 0 (this device) | 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 | — |
| +2 | K231912 | Therm-X | Zenith Technical Innovations | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro AthleteSummary page 4…Compression Device 510(k) Submitter Zenith Technical CoolSystems, Inc. ThermoTek, Inc. / Holder: Innovations, LLC 510(k) Number: K181149 K171685 K061866 Classification: Class II Class II Class II Regulat… | 2018 |
| * | K171685 | Med4 EliteSummary page 4…e 510(k) Submitter Zenith Technical CoolSystems, Inc. ThermoTek, Inc. / Holder: Innovations, LLC 510(k) Number: K181149 K171685 K061866 Classification: Class II Class II Class II Regulation 890.5650,… | 2017 |
| * | K061866 | Nanotherm, Vascutherm and Prothermo Therapy WrapsSummary page 4…Zenith Technical CoolSystems, Inc. ThermoTek, Inc. / Holder: Innovations, LLC 510(k) Number: K181149 K171685 K061866 Classification: Class II Class II Class II Regulation 890.5650, Powered 890.565… | 2006 |
| † | K131327 | Bioarterial Plus Arterial Blood Flow Enhancement System | 2013 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193550 | Therm-X | 2020 | 10 |
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 3 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 24 ancestors have a recall of any class.
- Of its descendants, K193550 (Zenith Technical Innovations, 2020) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K181149.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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-XPro, Therm-XPro Athlete, and Therm-XAT) combines cold, heat, contrast, and compression therapy.Therm-Xis 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-XPro and Therm-XPro Athlete systems also…
Read the full statement (124 words)
Therm-X(Therm-XPro, Therm-XPro Athlete, and Therm-XAT) combines cold, heat, contrast, and compression therapy.Therm-Xis 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-XPro and Therm-XPro Athlete systems also provide DVT therapy.Therm-XPro and Therm-XPro 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-XPro, Therm-XPro Athlete and Therm-XAT) 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/K190854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190854: Therm-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190854
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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