Neurology · 510(k) · 2023
Ceribell Status Epilepticus Monitor
Ceribell, Inc.. Cleared by FDA on 23 May 2023 under submission K223504, product code OMB (automatic event detection software for full-montage electroencephalograph). What FDA's record says, in FDA's words.
Device record · K223504
- Device. Ceribell Status Epilepticus MonitorDEVICE
- Company. Ceribell, Inc.COMPANY
- Decision. 23 May 2023, 510(k), substantially equivalent (traditional review); received 22 November 2022DECISION
- Panel. NeurologyPANEL
- Product code. OMB, Automatic Event Detection Software For Full-Montage ElectroencephalographCODE
- Regulation. 21 CFR 882.1400, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Ceribell Status Epilepticus Monitor software is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The Ceribell Status Epilepticus Monitor software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epilepticus as defined in the American Clinical Neurophysiology Society’s Guideline 14. The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment in acute-care environments. The device’s diagnosis of Electrographic Status Epilepticus provides one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient. The Ceribell Status Epilepticus Monitor is intended for diagnosis of Electrographic Status Epilepticus only. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The device is not intended for use in Epilepsy Monitoring Units.
The product code's definition, from FDA's classification record. 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
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 36 reports filed against devices carrying product code OMB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
25 June 2025 · Malfunction · NATUS BRAIN MONITOR BREAKOUT · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00015
PART 021911 NATUS BRAIN MONITOR BREAKOUT - THE CHANNEL LABELS ON THE DEVICE DO NOT MATCH WITH CHANNEL LABELS IN THE RECORDING AND REFER TO A DIFFERENT BRAIN LOCATION, LEADING TO MISREPRESENTATION OF THE EEG DATA.
25 June 2025 · Malfunction · NATUS BRAIN MONITOR BREAKOUT · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00014
PART 021911 NATUS BRAIN MONITOR BREAKOUT - THE CHANNEL LABELS ON THE DEVICE DO NOT MATCH WITH CHANNEL LABELS IN THE RECORDING AND REFER TO A DIFFERENT BRAIN LOCATION, LEADING TO MISREPRESENTATION OF THE EEG DATA.
21 May 2025 · Malfunction · IP PTZ HD ERGOJUST VIDEO EXTENSION · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00013
IP PTZ HD ERGOJUST VIDEO EXTENSION - ERGOJUST CART CHASSIS BREAKING. METAL ON POLE STARTED TO COMPLETELY SHEAR, MAKE SHIFT REPAIR HAS BEEN DONE TO KEEP IT IN PLACE.
27 March 2025 · Malfunction · UPPER MAST ASSEMBLY FOR ERGOJUST CART · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00011
UPPER MAST ASSEMBLY FOR ERGOJUST CART -USER STATED THEY WERE PUSHING THE CART DOWN THE HALL AND THE CAMERA TOWER FELL AND ALMOST HIT THEM ON THE HEAD.
27 March 2025 · Malfunction · UPPER MAST ASSEMBLY FOR ERGOJUST CART · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00012
UPPER MAST ASSEMBLY FOR ERGOJUST CART - SECOND EVENT - USER STATED THEY WERE PUSHING THE CART DOWN THE HALL AND THE CAMERA TOWER FELL AND ALMOST HIT THEM ON THE HEAD. THE SECOND TIME ONE OF THE CAMERA TOWERS BROKE AT THE MOUNTING CONNECTION.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OMB, in Neurology, from Ceribell, Inc., or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.