Cleared Special

K181179 - BrainScope One

K181179 is an FDA 510(k) clearance for BrainScope One, manufactured by Brainscope Company, Inc.. The device is a Class 2 Neurology device with product code PIW cleared through the Special 510(k) pathway after a 16-day FDA review.

K181179 · Brainscope Company, Inc. · Neurology device
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May 2018
Decision
16d
Days
Class 2
Risk

K181179 is an FDA 510(k) clearance for the BrainScope One. 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 May 18, 2018 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1450 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Brainscope Company, Inc. devices

FDA 510(k) Submission Details - K181179

510(k) Number K181179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2018
Decision Date May 18, 2018
Days to Decision 16 days
Submission Type Special
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
132d faster than avg
Panel avg: 148d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

PIW Device Classification - Class 2, Special Controls

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 K181179.
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
Ahead 300
K161068 · Brainscope Company, Inc. · Sep 2016
Brainscope Ahead 200
K143643 · Brainscope Company, Inc. · May 2015
BrainScope Ahead 100
DEN140025 · Brainscope Company, Inc. · Nov 2014