Cleared Traditional

BrainScope TBI (K190815) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K190815 · Brainscope Company, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
166d
Days
Class 2
Risk

K190815 is an FDA 510(k) clearance for the BrainScope TBI. 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 11, 2019 after a review of 166 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 K190815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2019
Decision Date September 11, 2019
Days to Decision 166 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
18d slower than avg
Panel avg: 148d · This submission: 166d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02477943 Completed Observational Industry-sponsored

Objective Brain Function Assessment of mTBI/Concussion in College Athletes

Objective Brain Function Assessment of mTBI From Initial Injury to Rehabilitation and Treatment Optimization in College Athletes

520
Patients (actual)
11
Sites
Condition studied Brain Injuries, Traumatic; Concussion, Mild; Concussion, Brain; Concussion, Intermediate; Concussion, Severe
Eligibility All sexes · 18 Years+
Principal investigator Leslie Prichep, Ph.D.
Sponsor BrainScope Company, Inc. (industry)
Started 2015-08-08 → Primary completion 2017-02-20 → Completed 2017-07-31
Primary outcome
Algorithm for Likelihood of being concussed
Secondary outcome
Advanced Neuroimaging in concussion
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K190815.
Nurochek-Pro System
K243426 · Headsafe Mfg Pty, Ltd. · Mar 2025
Nurochek-II System
K231914 · Headsafe Mfg Pty, Ltd. · Dec 2023
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