Cleared Traditional

Ceribell Delirium Monitor System

K251936 · Ceribell, Inc. · Neurology
Dec 2025
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K251936 is an FDA 510(k) clearance for the Ceribell Delirium Monitor System, a Neuropsychiatric Interpretative Electroencephalograph Assessment Aid (Class II — Special Controls, product code NCG), submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 8, 2025, 167 days after receiving the submission on June 24, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1440.

Submission Details

510(k) Number K251936 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2025
Decision Date December 08, 2025
Days to Decision 167 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NCG — Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1440
Definition Uses A Patient's Electroencephalograph (eeg) To Provide An Interpretation Of The Patient's Neuropsychiatric Condition. It Is Also Used Only As An Assessment Aid For A Medical Condition For Which There Exists Other Valid Methods Of Diagnosis."