Cleared Traditional

Ceribell Infant Seizure Detection Software

K252070 · Ceribell, Inc. · Neurology

Nov 2025

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K252070 is an FDA 510(k) clearance for the Ceribell Infant Seizure Detection Software, a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II — Special Controls, product code OMB), submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 21, 2025, 143 days after receiving the submission on July 1, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K252070 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2025
Decision Date	November 21, 2025
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMB — Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User