510(k) · Cleared
ClearedGame Ready GRPro 2.1 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cool Systems, Inc. (Dba Game Ready) · IRP Massager, Powered Inflatable Tube
Cleared on Oct 29, 2019 as substantially equivalent to K072620 (Coolsystems, Inc., 2007) after an 84-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Oct 29, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951769 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK951769 CryopressGrimm Scientific Industries, Inc. · 1995
- 2 generations backK071050 Game Ready Professional Therapy System, Model 550100, Game Ready…Coolsystems, Inc. · 2007 · Recalled
- 1 generation backK072620 Game Ready Classic System, Model 550550Coolsystems, Inc. · 2007
- This deviceK192114 Game Ready GRPro 2.1 SystemCool Systems, Inc. (Dba Game Ready) · 2019
- Descendant · cites it directly · 0 of its ownK193079 ICE COMPRESSION FIRST, DUO, & MOOVE SystemsMks Paris · 2021
Most influential descendants
Showing 1 of 1 · See all- K193079ICE COMPRESSION FIRST, DUO, & MOOVE SystemsMks Paris · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951769 | Cryopress | Grimm Scientific Industries, Inc. | 1995 | — |
| −2 | K071050 | Game Ready Professional Therapy System, Model 550100, Game Ready… | Coolsystems, Inc. | 2007 | 1 |
| −1 | K072620 | Game Ready Classic System, Model 550550 | Coolsystems, Inc. | 2007 | — |
| 0 (this device) | K192114 | Game Ready GRPro 2.1 System | Cool Systems, Inc. (Dba Game Ready) | 2019 | — |
| +1 | K193079 | ICE COMPRESSION FIRST, DUO, & MOOVE Systems | Mks Paris | 2021 | — |
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 |
|---|---|---|
| 2021 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072620 | Game Ready Classic System, Model 550550Summary page 5…DEVICES: The selected predicate device, the Game Ready Classic GR2 was cleared on October 31, 2007. CoolSystems® (dba Game Ready) is the owner of the predicate 510(k), K072620. Game Ready GRPro 2.1 System Section 5 – Page 2 of 8 COMPARISON… | 2007 |
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 |
|---|---|---|---|
| K193079 | ICE COMPRESSION FIRST, DUO, & MOOVE Systems | 2021 | 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 24 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K193079 (Mks Paris, 2021) 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 Game Ready GRPro 2.1 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/K192114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192114: Game Ready GRPro 2.1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192114
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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