Cleared Traditional

K192764 - NeuroOne Cortical Electrode

K192764 is the FDA 510(k) clearance for NeuroOne Cortical Electrode by Neuroone, Inc.. It is a Class 2 Neurology device (product code GYC) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K192764 · Neuroone, Inc. · Neurology device
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Nov 2019
Decision
57d
Days
Class 2
Risk

K192764 is an FDA 510(k) clearance for the NeuroOne Cortical Electrode. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Neuroone, Inc. (Minnetonka, US). The FDA issued a Cleared decision on November 26, 2019 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neuroone, Inc. devices

Submission Details

510(k) Number K192764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date November 26, 2019
Days to Decision 57 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 148d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Debra J Kridner
Debra Kridner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GYC Electrode, Cortical

All 14
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K192764.
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
K201931 · Dixi Medical · Oct 2021
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
K191346 · Blackrock Microsystems · Feb 2020
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
K191186 · Ad-Tech Medical Instrument Corporation · Jan 2020
AirRay Subdural Cortical Electrodes
K183437 · Cortec GmbH · Mar 2019
SD LTM STIM Cortical Stimulator
K180761 · Micromed S.P.A. · Jun 2018
g.Estim PRO
K173684 · G.Tec Medical Engineering GmbH · May 2018