510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181179Substantially Equivalent

BrainScope One

Brainscope, Bethesda MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181179 is the FDA 510(k) clearance record for BrainScope One, a class II device, cleared for Brainscope Company, Inc. on under FDA product code PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid). FDA's definition for product code PIW reads: "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...". FDA records list 8 510(k) clearances for Brainscope Company, Inc., from to . As of , FDA records show no recalls naming K181179.

Clearance record

Decision date
Received
(16 days to decision)
Product code
PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Regulation
21 CFR 882.1450
Device class
Class II
Review panel
Neurology
Applicant
Brainscope Company, Inc. 4350 E. W. Hwy., Suite 1050, Bethesda MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIW

Trailing 12 months

FDA records hold no clearances under product code PIW in the trailing twelve months.

FDA records show no clearances under product code PIW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PIW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260