510(k) · Cleared
ClearedBaylis Pain Management Generator-TD, 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 Dec 19, 2007 as substantially equivalent to K031950 (Baylis Medical Co., Inc., 2003) after a 106-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Dec 19, 2007
- Review
- 106 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031950 (2003). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK031950 Baylis Pain Management Generator, Models PMG-115-TD and PMG-230-TDBaylis Medical Co., Inc. · 2003
- This deviceK072478 Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TDBaylis Medical Co., Inc. · 2007
- Descendant · cites it directly · 0 of its ownK192491 Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc. · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK181864 Polaris RF Ablation SystemBaylis Medical Company, Inc. · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK093185 Owl Universal RF System Urf-3AP (ML)Diros Technology, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K192491Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc. · 2020 · cites it directly0descendants
- K181864Polaris RF Ablation SystemBaylis Medical Company, Inc. · 2019 · cites it directly0descendants
- K093185Owl Universal RF System Urf-3AP (ML)Diros Technology, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031950 | Baylis Pain Management Generator, Models PMG-115-TD and PMG-230-TD | Baylis Medical Co., Inc. | 2003 | — |
| 0 (this device) | K072478 | Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD | Baylis Medical Co., Inc. | 2007 | — |
| +1 | K192491 | Coolief Radiofrequency Generator (CRG) System | Avanos Medical, Inc. | 2020 | 1 |
| +1 | K181864 | Polaris RF Ablation System | Baylis Medical Company, Inc. | 2019 | 6 |
| +1 | K093185 | Owl Universal RF System Urf-3AP (ML) | Diros Technology, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K031950 | Baylis Pain Management Generator, Models PMG-115-TD and PMG-230-TDSummary page 1…GXD, GET Identification of Predicate Device Predicate device is the Baylis Pain Management Generator - TD, which is cleared under 510(k) Premarket Notification Number K031950. Device Description The Baylis Pain Management Generator - TD is a modification of the previously 510(k) cleared Baylis Pain Ma… | 2003 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K192491 (Avanos Medical, Inc., 2020) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.
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 with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath TM and Baylis Pain Management Probes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072478 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072478: Baylis Pain Management Generator-TD, 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 5, 2026. https://510kreport.com/device/K072478
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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