# K002389: Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector Cable/PMX-Bay-Bay

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Oct 23, 2000 after 80 days
- Product code: GXI (Probe, Radiofrequency Lesion)
- Device class: 2
- Regulation: 21 CFR 882.4725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K043442: Stryker RF Coaxial Bipolar Electrodes & Cannulae (2005), 17 descendants of its own
- K053082: Baylis Pain Management Cooled Probe, Model PMPC-18-150-6 (2005), 11 descendants of its own
- K153272: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (2016), 7 descendants of its own
- K061660: Stryker RF Parallel Bipolar Adaptor Cable (2006), 5 descendants of its own
- K180369: Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (2018), 4 descendants of its own

Source page: https://510kreport.com/device/K002389
Methodology: https://510kreport.com/methodology