Cleared Traditional

K181785 - Modified BrainScope One

K181785 is an FDA 510(k) clearance for Modified BrainScope One, manufactured by Brainscope Company, Inc.. The device is a Class 2 Neurology device with product code PIW cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K181785 · Brainscope Company, Inc. · Neurology device
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Dec 2018
Decision
169d
Days
Class 2
Risk

K181785 is an FDA 510(k) clearance for the Modified 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 December 19, 2018 after a review of 169 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

FDA 510(k) Submission Details - K181785

510(k) Number K181785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2018
Decision Date December 19, 2018
Days to Decision 169 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
21d slower than avg
Panel avg: 148d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K181785.
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
BrainScope One
K181179 · Brainscope Company, Inc. · May 2018
Ahead 300
K161068 · Brainscope Company, Inc. · Sep 2016
Brainscope Ahead 200
K143643 · Brainscope Company, Inc. · May 2015