# K231675: OneRF Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Neuroone Medical Technologies Corp.
- Decided: Dec 6, 2023 after 181 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
Longest line of descent: 5 generations back to K870028 (1987). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082051: Cosman G4 Radiofrequency Generator, Model RFG-4, Cosman Medical, Inc. (2008) Summary page 6.
- K010202: Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion Probes, Leslie W. Organ (2001) Summary page 6.

## Most influential descendants
- K251243: OneRF Trigeminal Nerve Radiofrequency Probes (2025), 0 descendants of its own

## Indications for use
The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

Source page: https://510kreport.com/device/K231675
Methodology: https://510kreport.com/methodology