Cleared Traditional

Atlas Stim Headbox (NK) (31-0601-0077); 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 · Neuralynx, Inc. · Neurology

Apr 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K250094 is an FDA 510(k) clearance for the Atlas Stim Headbox (NK) (31-0601-0077); 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), a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Neuralynx, Inc. (Bozeman, US). The FDA issued a Cleared decision on April 14, 2025, 90 days after receiving the submission on January 14, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number	K250094 FDA.gov
FDA Decision	Cleared 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