# K192764: NeuroOne Cortical Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Neuroone, Inc.
- Decided: Nov 26, 2019 after 57 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K850342 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082474: PMT Subdural Cortical Electrodes, Pmt Corp. (2009) Summary page 5.

## Indications for use
The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.

Source page: https://510kreport.com/device/K192764
Methodology: https://510kreport.com/methodology