# K053082: Baylis Pain Management Cooled Probe, Model PMPC-18-150-6

- Pathway: 510(k) (Special)
- Applicant: Baylis Medical Co., Inc.
- Decided: Nov 30, 2005 after 28 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002389 (2000). 1 ancestor in all.
11 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002389: Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector Cable/PMX-Bay-Bay, Baylis Medical Co., Inc. (2000) Summary page 1.

## 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
- K062937: Transdiscal System, Models TDP-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-Ppu (2007), 3 descendants of its own
- K163461: Coolief* Cooled RF Probe (2017), 1 descendant of its own

## Recalls of this device
- Jun 16, 2016 · Class II · Z-2391-2016: Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
- May 12, 2010 · Not classified · Z-1755-2010: Name of the device reflected on the product packing sleeve is incorrect.

## Indications for use
Baylis Pain management Cooled Probe will be used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.

Source page: https://510kreport.com/device/K053082
Methodology: https://510kreport.com/methodology