# K020354: Baylis Pain Management Generator (PMG), Models PMG-115 (Domestic), PMG-230 (International)

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: May 3, 2002 after 88 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K061660: Stryker RF Parallel Bipolar Adaptor Cable (2006), 5 descendants of its own
- K083528: Smith & Nephew Bipolar Adapter Cable, Model 72200022 (2009), 4 descendants of its own
- K111262: Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical Cables, Monop (2012), 3 descendants of its own
- K062758: Owl Urf-3AP (2006), 1 descendant of its own
- K241621: Da Vinci Monopolar and Bipolar Adapters (378896) (2024), 0 descendants of its own

## Indications for use
Baylis Pain Management Generator; Model PMG-115 (For Domestic Use) and Model PMG-230 (For International Use) is indicated for use to create lesions during neurological lesion procedures. The Baylis PMG is to be used with separately approved lesion/temperature probes such as Baylis Pain Management Probes and Oratec Spinecath™.

Source page: https://510kreport.com/device/K020354
Methodology: https://510kreport.com/methodology