Not Cleared Direct Expedited

BrainScope Ahead 100 (DEN140025) - FDA 510(k) Clearance

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN140025 · Brainscope Company, Inc. · Neurology device
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Nov 2014
Decision
89d
Days
Class 2
Risk

DEN140025 is an FDA 510(k) submission (not cleared) for the BrainScope Ahead 100. 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 Not Cleared (DENG) decision on November 17, 2014 after a review of 89 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Brainscope Company, Inc. devices

Submission Details

510(k) Number DEN140025 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 20, 2014
Decision Date November 17, 2014
Days to Decision 89 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics

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 DEN140025.
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