510(k) · Cleared
ClearedZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zamar Medical D.O.O. · IRP Massager, Powered Inflatable Tube
Cleared on May 5, 2025 as substantially equivalent to K171685 (Cool Systems, Inc. (Dba Game Ready), 2017) after a 235-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- May 5, 2025
- Review
- 235 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944567 (1995). 13 ancestors in all, the oldest K942796 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 3 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 2 generations backK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
- 1 generation backK171685 Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017
- This deviceK242754 ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)Zamar Medical D.O.O. · 2025
- Descendant · cites it directly · 0 of its ownK253919 Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −3 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −2 | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | Thermotek, Inc. | 2006 | — |
| −1 | K171685 | Med4 Elite | Cool Systems, Inc. (Dba Game Ready) | 2017 | — |
| 0 (this device) | K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. | 2025 | — |
| +1 | K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253919 | Cryo And Thermo Therapy System | 2026 | 0 |
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 5 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K253919 (Xiamen Weiyou Intelligent Technology Co., Ltd., 2026) has gone furthest, with 0 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. 2025, 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?
The Heat Exchange Equipment for Cryotherapy and Thermotherapy provides a combination of cold, heat, contrast, and compression therapies.
It is intended to treat post-surgical and trauma 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 or contrast) are indicated.
The equipment is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242754: ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242754
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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