Cleared Traditional

Ahead 300 (K161068) - FDA 510(k) Clearance

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

K161068 · Brainscope Company, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
160d
Days
Class 2
Risk

K161068 is an FDA 510(k) clearance for the Ahead 300. Classified as Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid (product code PIW), Class II - Special Controls.

Submitted by Brainscope Company, Inc. (Bethesda, US). The FDA issued a Cleared decision on September 22, 2016 after a review of 160 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1450 - 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 Brainscope Company, Inc. devices

Submission Details

510(k) Number K161068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2016
Decision Date September 22, 2016
Days to Decision 160 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
12d slower than avg
Panel avg: 148d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1450
Definition A Prescription Device That Uses A Patient¿s Electroencephalograph (eeg) To Provide An Interpretation Of The Structural Condition Of The Patient¿s Brain In The Setting Of Trauma. The Brain Injury Adjunctive Interpretive Eeg Assessment Aid Is For Use As An Adjunct To Standard Clinical Practice Only As An Assessment Aid For A Medical Condition For Which There Exists Other Valid Methods Of Diagnosis.
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 - PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

All 8
Devices cleared under the same product code (PIW) and FDA review panel - the closest regulatory comparables to K161068.
Nurochek-Pro System
K243426 · Headsafe Mfg Pty, Ltd. · Mar 2025
Nurochek-II System
K231914 · Headsafe Mfg Pty, Ltd. · Dec 2023
BrainScope TBI
K190815 · Brainscope Company, Inc. · Sep 2019
BrainScope TBI (Model: Ahead 400)
K183241 · Brainscope Company, Inc. · Feb 2019
Modified BrainScope One
K181785 · Brainscope Company, Inc. · Dec 2018
BrainScope One
K181179 · Brainscope Company, Inc. · May 2018