# K031950: Baylis Pain Management Generator, Models PMG-115-TD and PMG-230-TD

- Pathway: 510(k) (Abbreviated)
- Applicant: Baylis Medical Co., Inc.
- Decided: Jul 17, 2003 after 23 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072478: Baylis Pain Management Generator-TD, Models: PMG-115-TD and PMG-230-TD (2007), 3 descendants of its own
- K192491: Coolief Radiofrequency Generator (CRG) System (2020), 0 descendants of its own
- K181864: Polaris RF Ablation System (2019), 0 descendants of its own
- K093185: Owl Universal RF System Urf-3AP (ML) (2010), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K031950
Methodology: https://510kreport.com/methodology