510(k) · Cleared
ClearedCOOLIEF Cooled Radiofrequency Kit Advanced
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanos Medical, Inc. · GXI Probe, Radiofrequency Lesion
Cleared on Dec 22, 2020 as substantially equivalent to K163461 (Halyard Health, Inc., 2017) and 1 other predicate after a 74-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 22, 2020
- Review
- 74 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002389 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK002389 Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management…Baylis Medical Co., Inc. · 2000
- 3 generations backK053082 Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Baylis Medical Co., Inc. · 2005 · Recalled
- 2 generations backK062937 Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1…Baylis Medical Co., Inc. · 2007 · Recalled
- 1 generation backK163236 COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. · 2016
- This deviceK203066 COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002389 | Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector… | Baylis Medical Co., Inc. | 2000 | — |
| −3 | K053082 | Baylis Pain Management Cooled Probe, Model PMPC-18-150-6 | Baylis Medical Co., Inc. | 2005 | 2 |
| −2 | K062937 | Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1… | Baylis Medical Co., Inc. | 2007 | 1 |
| −1 | K163236 | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | 2016 | — |
| 0 (this device) | K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 GXI? 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 GXI device
- #1 K253907 Disposable Radiofrequency Cannulascore 12.7 · 6 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 |
|---|---|---|---|
| * | K163461 | Coolief* Cooled RF ProbeSummary page 4…There are no previous submissions for this change. Primary Predicate Device: Trade Name COOLIEF* Cooled Radiofrequency Probe 510(k) Number K163461 Manufacturer Halyard Health, Inc. (currently Avanos Medical, Inc.) Common Name Radiofrequency lesion… | 2017 |
| * | K163236 | COOLIEF Cooled Radiofrequency KitSummary page 4…GXI Review Panel (84) Neurology Secondary Predicate Device: Trade Name COOLIEF* Cooled Radiofrequency Kit 510(k) Number K163236 Manufacturer Halyard Health, Inc. (currently Avanos Medical, Inc.) Common Name Radiofrequency lesion… | 2016 |
| † | K072478 | Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD | 2007 |
| † | K031951 | Transdiscal System (Transdiscal Probe), Model TDP-17-150-6 | 2003 |
| † | K140658 | Thermogard Dispersive Electrodes, Thermogard Plus Abc Dispersive Electrodes | 2014 |
| † | K192491 | Coolief Radiofrequency Generator (CRG) System | 2020 |
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 20 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GXI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXI
183in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXI
98in 2025
MAUDE reports naming product code GXI, 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 | 4 | 87 | 3 | 1 |
| 2008 | 2 | — | 1 | 4 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 2 | — | 1 | 8 |
| 2011 | 3 | 64 | 0 | 5 |
| 2012 | 1 | — | 1 | 14 |
| 2013 | 1 | — | 1 | 25 |
| 2014 | 1 | — | 0 | 20 |
| 2015 | 1 | — | 0 | 23 |
| 2016 | 3 | 240 | 0 | 16 |
| 2017 | 3 | 125 | 1 | 150 |
| 2018 | 1 | — | 0 | 147 |
| 2019 | 3 | 63 | 1 | 93 |
| 2020 | 3 | 255 | 0 | 31 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 2 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 35 |
| 2024 | 0 | — | 0 | 45 |
| 2025 | 4 | 183 | 0 | 98 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site. This device is also indicated for creating…
Read the full statement (171 words)
The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.
The COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADV ANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVAN CED) to create RF lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203066: COOLIEF Cooled Radiofrequency Kit Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203066
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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