# K251243: OneRF Trigeminal Nerve Radiofrequency Probes

- Pathway: 510(k) (Traditional)
- Applicant: Neuroone Medical Technologies Corp.
- Decided: Aug 15, 2025 after 115 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
Longest line of descent: 6 generations back to K870028 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050084: Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit;, Cosman Medical, Inc. (2005) Summary page 7.
- K231675: OneRF Ablation System, Neuroone Medical Technologies Corp. (2023) Summary page 5.

## Indications for use
The NeuroOne OneRF Trigeminal Nerve Ablation System is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

Source page: https://510kreport.com/device/K251243
Methodology: https://510kreport.com/methodology