510(k) · Cleared
ClearedCryon-X Cold Compression
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jkh Health Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Oct 24, 2025 as substantially equivalent to K223541 (Jkh Health Co., Ltd., 2023) and 2 other predicates after a 29-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Oct 24, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K881632 (1988). 28 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 backK223541 Cold/Hot CompressionJkh Health Co., Ltd. · 2023
- This deviceK253150 Cryon-X Cold CompressionJkh Health Co., Ltd. · 2025
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 | K223541 | Cold/Hot Compression | Jkh Health Co., Ltd. | 2023 | — |
| 0 (this device) | K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | 2025 | — |
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 |
| 2014 | 1 | 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 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 |
|---|---|---|---|
| * | K223541 | Cold/Hot CompressionSummary page 5…: 21 CFR 890.5650, 21 CFR 890.5720, 21 CFR 870.5800 Device Class: II Use: Prescription 3. Predicate device Primary Predicate Device: Cold/Hot Compression 510(k) Number: K223541 Clearance Date: October 27, 2023 Submitter: JKH Health Co., Ltd. Predicate Device: Therm-X 510(k) Number: K193550 Clearance Date… | 2023 |
| * | K193550 | Therm-XSummary page 5…Predicate Device: Cold/Hot Compression 510(k) Number: K223541 Clearance Date: October 27, 2023 Submitter: JKH Health Co., Ltd. Predicate Device: Therm-X 510(k) Number: K193550 Clearance Date: February 28, 2020 Submitter: Zenith Technical Innovations, LLC Predicate Device: NICE1 510(k) Number: K143197 Cl… | 2020 |
| * | K143197 | Nice1Summary page 5…Predicate Device: Therm-X 510(k) Number: K193550 Clearance Date: February 28, 2020 Submitter: Zenith Technical Innovations, LLC Predicate Device: NICE1 510(k) Number: K143197 Clearance Date: December 23, 2014 Submitter: Nice Recovery Systems, LLC Reference Device: NanoTherm and VascuTherm Systems 510(k… | 2014 |
| † | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | 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 37 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 28 ancestors have a recall of any class.
- 1 other device also cites its predicate K223541.
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?
Cryon-X Pro The private-label Cryon-X Pro device combines cold, heat, contrast, and compression therapy. It 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) is indicated. The device may optionally provide DVT therapy, intended to…
Read the full statement (178 words)
Cryon-X Pro
The private-label Cryon-X Pro device combines cold, heat, contrast, and compression therapy. It 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) is indicated.
The device may optionally provide DVT therapy, 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.
This device is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.
Cryon-X One
The private-label Cryon-X One device combines cold and compression therapy. It 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 be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253150: Cryon-X Cold Compression.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253150
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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