510(k) · Cleared
ClearedBaylis Pain Management Generator, Models PMG-115-TD and PMG-230-TD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Co., Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 17, 2003 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 17, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK031950 Baylis Pain Management Generator, Models PMG-115-TD and PMG-230-TDBaylis Medical Co., Inc. · 2003
- Descendant · cites it directly · 3 of its ownK072478 Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TDBaylis Medical Co., Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK192491 Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK181864 Polaris RF Ablation SystemBaylis Medical Company, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK093185 Owl Universal RF System Urf-3AP (ML)Diros Technology, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K072478Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TDBaylis Medical Co., Inc. · 2007 · cites it directly3descendants
- K192491Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc. · 2020 · 2 generations on0descendants
- K181864Polaris RF Ablation SystemBaylis Medical Company, Inc. · 2019 · 2 generations on0descendants
- K093185Owl Universal RF System Urf-3AP (ML)Diros Technology, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K192491 | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | 2020 | 1 |
| +2 | K181864 | Polaris RF Ablation System | Baylis Medical Company, Inc. | 2019 | 6 |
| +2 | K093185 | Owl Universal RF System Urf-3AP (ML) | Diros Technology, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072478 | Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD | 2007 | 3 |
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?
- Of its descendants, K072478 (Baylis Medical Co., Inc., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Baylis Pain Management Generator-TD; Model PMG- 115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) 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 Baylis PMG-TD is to be used in conjunction with separately approved probes such as Baylis Transdiscal Probe, Oratec SpinecathTM and Baylis Pain Management Probes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031950: Baylis Pain Management Generator, Models PMG-115-TD and PMG-230-TD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031950
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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