Cleared Traditional

K251936 - Ceribell Delirium Monitor System

K251936 is an FDA 510(k) clearance for Ceribell Delirium Monitor System, manufactured by Ceribell, Inc.. The device is a Class 2 Neurology device with product code NCG cleared through the Traditional 510(k) pathway after a 167-day FDA review.

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

K251936 is an FDA 510(k) clearance for the Ceribell Delirium Monitor System. Classified as Neuropsychiatric Interpretative Electroencephalograph Assessment Aid (product code NCG), Class II - Special Controls.

Submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 8, 2025 after a review of 167 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1440 - 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 Ceribell, Inc. devices

FDA 510(k) Submission Details - K251936

510(k) Number K251936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 148d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

NCG Device Classification - Class 2, Special Controls

Product Code NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Device Class Class 2 - 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."
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.