Medical Device Manufacturer · US , Washington , DC

Brainscope Company, Inc. - FDA 510(k) Cleared Devices

8 submissions · 7 cleared · Since 2009

Recent clearances: BrainScope TBI, BrainScope TBI (Model: Ahead 400), Modified BrainScope One

Total

Cleared

Denied

Brainscope Company, Inc. has 7 FDA 510(k) cleared medical devices. Based in Washington, US.

Historical record: 7 cleared submissions from 2009 to 2019. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Brainscope Company, Inc. Filter by specialty or product code using the sidebar.

1 device has linked clinical trial registered on ClinicalTrials.gov.

Brainscope Company, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Brainscope Company, Inc.

8 devices

1-8 of 8

Cleared CT Sep 11, 2019

BrainScope TBI (Model: Ahead 400)

K183241 · PIW

Neurology · 90d

Cleared Dec 19, 2018

Modified BrainScope One

Not Cleared Nov 17, 2014

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 02, 2026

Brainscope Company, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Brainscope Company, Inc.

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