Cleared Traditional

K191346 - Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191346 · Blackrock Microsystems · Neurology device
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Optimized for regulatory review, auditing and printing
Feb 2020
Decision
270d
Days
Class 2
Risk

K191346 is an FDA 510(k) clearance for the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids). Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Blackrock Microsystems (Salt Lake City, US). The FDA issued a Cleared decision on February 14, 2020 after a review of 270 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Blackrock Microsystems devices

Submission Details

510(k) Number K191346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2019
Decision Date February 14, 2020
Days to Decision 270 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 148d · This submission: 270d
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 Peers - GYC Electrode, Cortical

All 31
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K191346.
Atlas Stim Headbox (NK) (31-0601-0077)
K250094 · Neuralynx, Inc. · Apr 2025
Layer 7-T
K242618 · Precision Neuroscience, Corp. · Mar 2025
WISE Cortical Strip (WCS)
K221123 · Wise S.R.L. · Nov 2022
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
K211954 · Spes Medica Srl · Nov 2022
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
K201931 · Dixi Medical · Oct 2021