510(k) · Cleared
ClearedCOOLIEF Cooled Radiofrequency Kit
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 Dec 16, 2016 as substantially equivalent to K062937 (Baylis Medical Co., Inc., 2007) after a 29-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Dec 16, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002389 (2000). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002389 Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management…Baylis Medical Co., Inc. · 2000
- 2 generations backK053082 Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Baylis Medical Co., Inc. · 2005 · Recalled
- 1 generation backK062937 Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1…Baylis Medical Co., Inc. · 2007 · Recalled
- This deviceK163236 COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. · 2016
- 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 |
|---|---|---|---|---|---|
| −3 | K002389 | Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector… | Baylis Medical Co., Inc. | 2000 | — |
| −2 | K053082 | Baylis Pain Management Cooled Probe, Model PMPC-18-150-6 | Baylis Medical Co., Inc. | 2005 | 2 |
| −1 | K062937 | Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1… | Baylis Medical Co., Inc. | 2007 | 1 |
| 0 (this device) | K163236 | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | 2016 | — |
| +1 | 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 |
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 |
|---|---|---|---|
| * | K062937 | Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1…Summary page 5…TransDiscal System including models Baylis TDP-17-150-6, TDI-17-150, TDA-PPU-1, Medical TDA-TBK-1, TDX-Y-TSW-TDP, TDX- K062937 Company PMG-PPU Prior Submission: There was no prior submission for the COOLIEF* Cooled Radiofrequen… | 2007 |
| † | K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH | 2015 |
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 16 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K203066 (Avanos Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062937.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 HALYARD* COOLIEF* Cooled Radiofrequency Kit, in combination with the HALYARD* Radiofrequency (RF) Generator (PMG-BASIC/PMG-ADVANCED) (formerly Baylis Pain Management Generator or KIMBERLY-CLARK® Pain Management Generator) is intended for the creation of Radio-Frequency (RF) heat lesions in nervous tissue for the relief of pain, and 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/K163236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163236: COOLIEF Cooled Radiofrequency Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163236
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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