510(k) · Cleared
ClearedCoolief* Cooled RF Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Halyard Health, Inc. · GXI Probe, Radiofrequency Lesion
Cleared on Apr 13, 2017 as substantially equivalent to K053082 (Baylis Medical Co., Inc., 2005) after a 125-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Apr 13, 2017
- Review
- 125 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002389 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002389 Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management…Baylis Medical Co., Inc. · 2000
- 1 generation backK053082 Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Baylis Medical Co., Inc. · 2005 · Recalled
- This deviceK163461 Coolief* Cooled RF ProbeHalyard Health, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK203066 COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K203066COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002389 | Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector… | Baylis Medical Co., Inc. | 2000 | — |
| −1 | K053082 | Baylis Pain Management Cooled Probe, Model PMPC-18-150-6 | Baylis Medical Co., Inc. | 2005 | 2 |
| 0 (this device) | K163461 | Coolief* Cooled RF Probe | Halyard Health, Inc. | 2017 | — |
| +1 | K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (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 |
|---|---|---|---|
| * | K053082 | Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Summary page 5…ly Marketed Predicate Device: Trade Name Pain Management Cooled Probe 510(k) Number K053082 Product Code GXI Manufacturer Halya… | 2005 |
| † | K031951 | Transdiscal System (Transdiscal Probe), Model TDP-17-150-6 | 2003 |
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 |
|---|---|---|---|
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | 2020 | 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 17 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K203066 (Avanos Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K053082.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Probe is to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163461: Coolief* Cooled RF Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163461
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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