510(k) · Cleared
ClearedCryo-Thermo Compression Device (FGK002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Microport Rehabtech (Group) Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Mar 8, 2023 as substantially equivalent to K193550 (Zenith Technical Innovations, 2020) and 1 other predicate after a 232-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Mar 8, 2023
- Review
- 232 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K881632 (1988). 26 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
- 6 generations backK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
- 5 generations backK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
- 4 generations backK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
- 3 generations backK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- 2 generations backK190854 Therm-XZenith Technical Innovations · 2019
- 1 generation backK193550 Therm-XZenith Technical Innovations · 2020
- This deviceK222136 Cryo-Thermo Compression Device (FGK002)Suzhou Microport Rehabtech (Group) Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881632 | Flowtron DVT System AC500 Pump, L501 Garment | Huntleigh Technology, Inc. | 1988 | — |
| −6 | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | Bio Compression Systems, Inc. | 2006 | — |
| −5 | K072666 | Bioarterial Plus, Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2007 | — |
| −4 | K131327 | Bioarterial Plus Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2013 | — |
| −3 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| −2 | K190854 | Therm-X | Zenith Technical Innovations | 2019 | — |
| −1 | K193550 | Therm-X | Zenith Technical Innovations | 2020 | — |
| 0 (this device) | K222136 | Cryo-Thermo Compression Device (FGK002) | Suzhou Microport Rehabtech (Group) 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 |
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? (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 |
|---|---|---|---|
| * | K193550 | Therm-XSummary page 4…e Class: Class II 1. Substantial Equivalence Claimed To Cryo-Thermo Compression Device is substantially equivalent to Therm-X cleared under (K193550) and Med4 Elite™ cleared under K171685. The predicate devices are listed in Table 1. Table… | 2020 |
| * | K171685 | Med4 EliteSummary page 4…ss II 1. Substantial Equivalence Claimed To Cryo-Thermo Compression Device is substantially equivalent to Therm-X cleared under (K193550) and Med4 Elite™ cleared under K171685. The predicate devices are listed in Table 1. Table 1 Table of Predicates Comparison Devic… | 2017 |
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 35 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 26 ancestors have a recall of any class.
- 4 other devices also cite its predicate K193550.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Cryo-Thermo Compression Device combines cold, heat and compression therapies.
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) are indicated.
It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics and athletic training settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222136 · printed Nov 3, 2026
Cite this page
510(k) Report. “K222136: Cryo-Thermo Compression Device (FGK002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K222136
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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