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BrainScope One

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181179

by Brainscope Company, Inc.

Identifiers

510(k) Number
K181179 FDA 510(k)
FDA Product Code
PIW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1450 FDA 510(k)
Regulation Number
882.1450 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BrainScope One is a Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid, classified under FDA regulation 882.1450. This portable device integrates electroencephalography (EEG) technology to provide objective, interpretive assessments of brain function, aiding in the evaluation of mild traumatic brain injuries (mTBI), including concussions and structural abnormalities such as intracranial hemorrhages. It serves as a diagnostic adjunct to clinical evaluations by offering rapid, non-invasive electrical activity analysis of the brain.

The BrainScope One is supplied as a Class II medical device, cleared by the FDA under 510(k) Special Review (K181179) with a decision classification of Substantially Equivalent. It is intended for single-use in clinical settings, including emergency departments, sports medicine, and neurology, where immediate diagnostic clarity is critical. The device requires no special storage conditions beyond standard environmental parameters and is designed for use in MRI-safe environments, though it is not itself an MRI-compatible imaging modality. No additional sterility or reprocessing is required beyond manufacturer instructions.

Frequently asked questions

What clinical settings is the BrainScope One designed to support, and how does it assist in patient evaluation?

The BrainScope One is specifically designed for use in clinical settings like emergency departments, sports medicine facilities, and neurology clinics where rapid assessment of brain function is critical. It serves as a diagnostic adjunct by providing objective, interpretive EEG-based evaluations of brain activity, aiding in the identification of mild traumatic brain injuries (mTBI), concussions, and structural abnormalities such as intracranial hemorrhages. Its portable and non-invasive design allows for quick, on-site analysis to complement clinical evaluations.

Is the BrainScope One reusable, or is it intended for single-use? What does this mean for clinical workflows?

The BrainScope One is intended for single-use only, meaning each device is designed for one patient evaluation before disposal. This eliminates the need for sterilization or reprocessing, simplifying clinical workflows by reducing handling and contamination risks. Clinicians should follow manufacturer instructions for proper disposal after use.

What storage requirements does the BrainScope One have, and can it be used in environments with MRI equipment?

The BrainScope One does not require special storage conditions beyond standard environmental parameters (e.g., temperature and humidity within typical clinical ranges). While it is MRI-safe—meaning it can be used in environments with MRI equipment without interfering with scans—it is not an MRI-compatible imaging modality itself. This means it provides EEG-based assessments independently of MRI scans.

How does the regulatory pathway for the BrainScope One affect its use in clinical practice?

The BrainScope One was cleared by the FDA under a 510(k) Special Review (K181179) as a Class II device, classified under regulation 882.1450. This clearance confirms its substantial equivalence to a predicate device and establishes its safety and effectiveness for adjunctive EEG-based brain injury assessments. Clinicians can rely on this regulatory pathway to ensure the device meets FDA standards for use in evaluating mild traumatic brain injuries and structural abnormalities.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BrainScope Company, Inc. - Wikipedia, BrainScope - Team, BrainScope - LinkedIn, Brainscope - floodgatemedical.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainscope Company, Inc.

Sources (1)

  • FDA 510(k) K181179 24 fields · synced Sep 19, 2026