510(k) · Cleared
Recalled · Class II · 2023Coolief Radiofrequency Generator (CRG) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanos Medical, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Feb 21, 2020 as substantially equivalent to K072478 (Baylis Medical Co., Inc., 2007) after a 163-day review. Its family tree reaches back 2 generations to 2003. It has been recalled once.
- Decided
- Feb 21, 2020
- Review
- 163 days
- Class
- Class II
- Product code
- GXD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031950 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK031950 Baylis Pain Management Generator, Models PMG-115-TD and PMG-230-TDBaylis Medical Co., Inc. · 2003
- 1 generation backK072478 Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TDBaylis Medical Co., Inc. · 2007
- This deviceK192491 Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031950 | Baylis Pain Management Generator, Models PMG-115-TD and PMG-230-TD | Baylis Medical Co., Inc. | 2003 | — |
| −1 | K072478 | Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD | Baylis Medical Co., Inc. | 2007 | — |
| 0 (this device) | K192491 | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | 2020 | — |
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 GXD? 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 GXD device
- #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 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 |
|---|---|---|---|
| * | K072478 | Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TDSummary page 4…Number Baylis Medical Company (Currently Owned by Avanos Baylis Pain Management Generator – TD K072478 Medical, Inc.) DEVICE DESCRIPTION The COOLIEF* Radiofrequency Generator (CRG) System uses controlled radiofrequency en… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2023 | Class II | Z-2622-2023 | Process change control | Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. |
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 12.2 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K072478.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GXD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXD
185in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXD
88in 2025
MAUDE reports naming product code GXD, 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 | 185 | 0 | 10 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 1 | 69 |
| 2011 | 2 | — | 0 | 89 |
| 2012 | 0 | — | 0 | 77 |
| 2013 | 0 | — | 0 | 119 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 67 |
| 2016 | 0 | — | 1 | 51 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 156 |
| 2019 | 1 | — | 1 | 195 |
| 2020 | 2 | — | 0 | 138 |
| 2021 | 0 | — | 0 | 154 |
| 2022 | 1 | — | 0 | 84 |
| 2023 | 2 | — | 1 | 54 |
| 2024 | 2 | — | 0 | 63 |
| 2025 | 1 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192491 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192491: Coolief Radiofrequency Generator (CRG) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192491
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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