510(k) · Neurology

Ceribell Status Epilepticus Monitor

by Ceribell, Inc.

Ceribell Status Epilepticus Monitor is an AI-enabled medical device from Ceribell, Inc. that the U.S. FDA cleared through 510(k) K223504 on May 23, 2023. Its lead review panel is Neurology and its primary product code is OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph).

See also FDA-cleared AI neurology devices in 2023, all FDA AI clearances in 2023, top neurology AI devices.

Key facts

Submission numberK223504
Pathway510(k)
Date of final decision
Company (FDA list)Ceribell, Inc.
Lead review panelNeurology
Primary product codeOMB — Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant (openFDA)Ceribell, Inc.
Applicant locationSunnyvale, CA, US
Device classClass 2
Regulation number21 CFR 882.1400
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Ceribell Status Epilepticus Monitor went through this pathway (K223504).

openFDA lists it as a Class 2 device under 21 CFR 882.1400. Class II devices are moderate risk and are subject to general and special controls.

Product code OMB covers 8 devices on the FDA AI list. By decision date, this device is #2 of 8 under that code. Ceribell, Inc. has 2 AI-enabled devices on the list, and the Neurology panel accounts for 73 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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