# K181864: Polaris RF Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Jan 2, 2019 after 174 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002389 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072478: Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD, Baylis Medical Co., Inc. (2007) Summary page 5.
- K062937: Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-Ppu, Baylis Medical Co., Inc. (2007) Summary page 5.
- K053082: Baylis Pain Management Cooled Probe, Model PMPC-18-150-6, Baylis Medical Co., Inc. (2005) Summary page 5.
- K002389: Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector Cable/PMX-Bay-Bay, Baylis Medical Co., Inc. (2000) Summary page 5.
- K972846: BMC RF Cannula, Baylis Medical Co., Inc. (1998) Summary page 5.

## Recalls of this device
- Jun 8, 2020 · Class II · Z-2690-2020: 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: 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: 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: 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: 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: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

## Indications for use
The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue.

Source page: https://510kreport.com/device/K181864
Methodology: https://510kreport.com/methodology