Cleared Traditional

K250094 - Atlas Stim Headbox (NK) (31-0601-0077) (FDA 510(k) Clearance)

Also includes:
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)

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

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

Submission Details

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.

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 K250094.
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