Cleared Traditional

K250094 - Atlas Stim Headbox (NK) (31-0601-0077)

Also marketed or referenced as:
Atlas Stim Headbox (Touchproof) (31-0601-0089) Atlas Stim Headbox (HD) (31-0601-0132) ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001) ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002) ATLAS Stim Headbox Software (36-0301-0006) Atlas Headbox Interface Cable (NK) (31-0204-003) Atlas Headbox Interface Cable (Touchproof) (31-0204-004) Atlas Headbox Interface Cable (HD) (31-0204-005) Atlas Headbox Expansion Panel (31-0607-0014)

K250094 is an FDA 510(k) clearance for Atlas Stim Headbox (NK) (31-0601-0077), manufactured by Neuralynx, Inc.. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K250094 · Neuralynx, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
90d
Days
Class 2
Risk

K250094 is an FDA 510(k) clearance for the Atlas Stim Headbox (NK) (31-0601-0077). Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Neuralynx, Inc. (Bozeman, US). The FDA issued a Cleared decision on April 14, 2025 after a review of 90 days - within the typical 510(k) review window.

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 Neuralynx, Inc. devices

FDA 510(k) Submission Details - K250094

510(k) Number K250094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2025
Decision Date April 14, 2025
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYC Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K250094.
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Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
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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