510(k) · Cleared
ClearedPolar Care Wave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breg, Inc. · IRP Massager, Powered Inflatable Tube
Cleared on Mar 1, 2019 as substantially equivalent to K072620 (Coolsystems, Inc., 2007) and 1 other predicate after a 60-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Mar 1, 2019
- Review
- 60 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K944567 (1995). 13 ancestors in all, the oldest K942796 (1995). 3 later devices descend from it, 3 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 deviceK183702 Polar Care WaveBreg, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK242940 Xrecovery (XR-001)Shenzhen Xinrun Electric Appliances Co, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK240986 Cold CompressionJkh Health Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK213097 Armory MotionPain Management Technologies, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView 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) | K183702 | Polar Care Wave | Breg, Inc. | 2019 | — |
| +1 | K242940 | Xrecovery (XR-001) | Shenzhen Xinrun Electric Appliances Co, Ltd. | 2024 | — |
| +1 | K240986 | Cold Compression | Jkh Health Co., Ltd. | 2024 | — |
| +1 | K213097 | Armory Motion | Pain Management Technologies, Inc. | 2022 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K072620 | Game Ready Classic System, Model 550550Summary page 4…fication Panel: Physical Medicine PREDICATE DEVICE: Predicate 510(k) Device Name Company Primary K072620 Game Ready Classic System CoolSystems, Inc. Secondary K171685 Med4 Elite… | 2007 |
| * | K171685 | Med4 EliteSummary page 4…Device Name Company Primary K072620 Game Ready Classic System CoolSystems, Inc. Secondary K171685 Med4 Elite CoolSystems, Inc. PRODUCT DESCRIPTION: The Polar Care Wave system is an AC powere… | 2017 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 5 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K242940 (Shenzhen Xinrun Electric Appliances Co, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K072620.
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?
The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183702: Polar Care Wave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183702
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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