510(k) · Cleared
ClearedGame Ready Classic System, Model 550550
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coolsystems, Inc. · IRP Massager, Powered Inflatable Tube
Cleared on Oct 31, 2007 as substantially equivalent to K071050 (Coolsystems, Inc., 2007) after a 44-day review. Its family tree reaches back 2 generations to 1995. 23 later devices descend from it.
- Decided
- Oct 31, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951769 (1995). 3 ancestors in all. 23 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK951769 CryopressGrimm Scientific Industries, Inc. · 1995
- 1 generation backK071050 Game Ready Professional Therapy System, Model 550100, Game Ready…Coolsystems, Inc. · 2007 · Recalled
- This deviceK072620 Game Ready Classic System, Model 550550Coolsystems, Inc. · 2007
- Descendant · cites it directly · 21 of its ownK171685 Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017
- Descendant · cites it directly · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- Descendant · 2 generations on · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019
- Descendant · 2 generations on · 10 of its ownK193550 Therm-XZenith Technical Innovations · 2020
- Descendant · 3 generations on · 3 of its ownK223729 FLOWpressoMedella Health Limited · 2023
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K171685Med4 EliteCool Systems, Inc. (Dba Game Ready) · 2017 · cites it directly21descendants
- K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · cites it directly12descendants
- K190854Therm-XZenith Technical Innovations · 2019 · 2 generations on11descendants
- K193550Therm-XZenith Technical Innovations · 2020 · 2 generations on10descendants
- K223729FLOWpressoMedella Health Limited · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951769 | Cryopress | Grimm Scientific Industries, Inc. | 1995 | — |
| −1 | K071050 | Game Ready Professional Therapy System, Model 550100, Game Ready… | Coolsystems, Inc. | 2007 | 1 |
| 0 (this device) | K072620 | Game Ready Classic System, Model 550550 | Coolsystems, Inc. | 2007 | — |
| +1 | K171685 | Med4 Elite | Cool Systems, Inc. (Dba Game Ready) | 2017 | — |
| +1 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| +2 | K190854 | Therm-X | Zenith Technical Innovations | 2019 | — |
| +2 | K193550 | Therm-X | Zenith Technical Innovations | 2020 | — |
| +3 | K223729 | FLOWpresso | Medella Health Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071050 | Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed…Summary page 1…g pack C. Predicate Device: The Game Ready Classic System issubstantially equivalent to the Game Ready System, cleared under 510(k) K071050, andcurrently legally marketed by CoolSystems, Inc. D. Device Description: The Game Ready Classic System is comprised of… | 2007 |
What descends from it? (23)
See all 234 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 12 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K171685 (Cool Systems, Inc. (Dba Game Ready), 2017) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K071050.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Game Ready Classic 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K072620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072620: Game Ready Classic System, Model 550550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072620
Report an extraction error
Are you the manufacturer?
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