510(k) · Cleared
Recalled · Class II · 2020Polaris RF Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Company, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Jan 2, 2019 as substantially equivalent to K072478 (Baylis Medical Co., Inc., 2007) and 4 other predicates after a 174-day review. Its family tree reaches back 3 generations to 2000. It has been recalled 6 times.
- Decided
- Jan 2, 2019
- Review
- 174 days
- Class
- Class II
- Product code
- GXD
- Recalls
- 6
- Predicates
- 5
Its longest line of descent runs back 3 generations to K002389 (2000). 7 ancestors in all, the oldest K972846 (1998). No later device cites it as a predicate yet.
- 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 deviceK181864 Polaris RF Ablation SystemBaylis Medical Company, Inc. · 2019
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) | K181864 | Polaris RF Ablation System | Baylis Medical Company, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 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 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? (5)
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 5…7.1: Predicate Devices Predicate Device Manufacturer 510(k) Baylis Pain Management Generator-TD K072478 Baylis TransDiscal System K062937 Baylis Pain Management Cooled Probe Halyar… | 2007 |
| * | K062937 | Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1…Summary page 5…rer 510(k) Baylis Pain Management Generator-TD K072478 Baylis TransDiscal System K062937 Baylis Pain Management Cooled Probe Halyard Health* K053082 Baylis Pain Management Probe and… | 2007 |
| * | K053082 | Baylis Pain Management Cooled Probe, Model PMPC-18-150-6Summary page 5…K072478 Baylis TransDiscal System K062937 Baylis Pain Management Cooled Probe Halyard Health* K053082 Baylis Pain Management Probe and K002389 Connector Cable BMC RF Cannula… | 2005 |
| * | K002389 | Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector…Summary page 5…K062937 Baylis Pain Management Cooled Probe Halyard Health* K053082 Baylis Pain Management Probe and K002389 Connector Cable BMC RF Cannula K972846 *Note: Originally submitted by Bay… | 2000 |
| * | K972846 | BMC RF CannulaSummary page 5…53082 Baylis Pain Management Probe and K002389 Connector Cable BMC RF Cannula K972846 *Note: Originally submitted by Baylis Medical Company Inc. as the manufacturer, but product line has since been acquired by Haly… | 1998 |
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 |
|---|---|---|---|---|
| Jun 8, 2020 | Class II | Z-2690-2020 | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. |
| Jun 8, 2020 | Class II | Z-2695-2020 | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. |
| Jun 8, 2020 | Class II | Z-2694-2020 | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. |
| Jun 8, 2020 | Class II | Z-2693-2020 | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. |
| Jun 8, 2020 | Class II | Z-2691-2020 | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. |
| Jun 8, 2020 | Class II | Z-2692-2020 | Under Investigation by firm | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 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. 2019, 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?
The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181864 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181864: Polaris RF Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181864
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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