510(k) · Cleared
ClearedTherm-X (Home); Therm-X (AT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zenith Technical Innovations · JOW Sleeve, Limb, Compressible
Cleared on Jun 21, 2024 as substantially equivalent to K231912 (Zenith Technical Innovations, 2023) and 1 other predicate after a 157-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Jun 21, 2024
- Review
- 157 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K881632 (1988). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
- 7 generations backK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
- 6 generations backK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
- 5 generations backK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
- 4 generations backK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- 3 generations backK190854 Therm-XZenith Technical Innovations · 2019
- 2 generations backK193550 Therm-XZenith Technical Innovations · 2020
- 1 generation backK231912 Therm-XZenith Technical Innovations · 2023
- This deviceK240125 Therm-X (Home); Therm-X (AT)Zenith Technical Innovations · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881632 | Flowtron DVT System AC500 Pump, L501 Garment | Huntleigh Technology, Inc. | 1988 | — |
| −7 | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | Bio Compression Systems, Inc. | 2006 | — |
| −6 | K072666 | Bioarterial Plus, Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2007 | — |
| −5 | K131327 | Bioarterial Plus Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2013 | — |
| −4 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| −3 | K190854 | Therm-X | Zenith Technical Innovations | 2019 | — |
| −2 | K193550 | Therm-X | Zenith Technical Innovations | 2020 | — |
| −1 | K231912 | Therm-X | Zenith Technical Innovations | 2023 | — |
| 0 (this device) | K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | 2024 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K231912 | Therm-XSummary page 6…Device 510(k) Submitter / Zenith Technical Innovations, ThermoTek, Inc. Holder: LLC. (Zenith) 510(k) Number: K231912 K061866 Classification: Class II Class II Regulation Num… | 2023 |
| * | K061866 | Nanotherm, Vascutherm and Prothermo Therapy WrapsSummary page 6…Zenith Technical Innovations, ThermoTek, Inc. Holder: LLC. (Zenith) 510(k) Number: K231912 K061866 Classification: Class II Class II Regulation Number: 890.5650, Powered Inf… | 2006 |
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 36 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 27 ancestors have a recall of any class.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat contrast, and compression therapy. Therm-X (Therm-X Home and Therm-X AT) 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. The Therm-X (Therm-X Home and…
Read the full statement (163 words)
Therm-X (Therm-X Home and Therm-X AT) combines cold, heat contrast, and compression therapy.
Therm-X (Therm-X Home and Therm-X AT) 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. The Therm-X (Therm-X Home and Therm-X AT) is also intended for treatment of disorders associated with vascular or lymphatic insufficiency, such as lymphedema and chronic venous insufficiency (CVI).
Therm-X Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy 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 Home 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240125: Therm-X (Home); Therm-X (AT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240125
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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