510(k) · Cleared
Recalled · 2010Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-Ppu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Co., Inc. · GXI Probe, Radiofrequency Lesion
Cleared on Jan 8, 2007 as substantially equivalent to K031951 (Baylis Medical Co., Inc., 2003) and 1 other predicate after a 102-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 8, 2007
- Review
- 102 days
- Class
- Class II
- Product code
- GXI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002389 (2000). 3 ancestors in all. 3 later devices descend from it, 2 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 deviceK062937 Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1…Baylis Medical Co., Inc. · 2007
- Descendant · cites it directly · 1 of its ownK163236 COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK203066 COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK181864 Polaris RF Ablation SystemBaylis Medical Company, Inc. · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. · 2016 · cites it directly1descendant
- K203066COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc. · 2020 · 2 generations on0descendants
- K181864Polaris RF Ablation SystemBaylis Medical Company, Inc. · 2019 · 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) | K062937 | Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1… | Baylis Medical Co., Inc. | 2007 | — |
| +1 | K163236 | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | 2016 | — |
| +2 | K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | 2020 | — |
| +1 | K181864 | Polaris RF Ablation System | Baylis Medical Company, Inc. | 2019 | 6 |
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 |
|---|---|---|
| 2016 | 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 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? (2)
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 |
|---|---|---|---|
| * | K031951 | Transdiscal System (Transdiscal Probe), Model TDP-17-150-6Summary page 1…ce Code: GXI 2.3 Identification of Predicate Device Predicate devices are the Baylis TransDiscallM System, which is cleared under 510(k) Premarket Notification Number K03 195 1, and the Baylis Pain Management Cooled Probe, which is cleared under 5 10(k) Premarket Notification Number K053082. 51 0(k) A… | 2003 |
| * | K053082 | Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Summary page 1…s cleared under 510(k) Premarket Notification Number K03 195 1, and the Baylis Pain Management Cooled Probe, which is cleared under 5 10(k) Premarket Notification Number K053082. 51 0(k) Application 2 " Bay/… | 2005 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2010 | Not classified | Z-1755-2010 | Error in labeling | Name of the device reflected on the product packing sleeve is incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 5.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K163236 (Halyard Health, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031951.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Baylis TransDiscal System, used in combination with the Baylis Pain Management Generator, is intended for the creation of Radio Frequency (RF) lesions in nervous tissue including that which is situated in intervertebral disc material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062937 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062937: Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-Ppu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062937
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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