# K223504: Ceribell Status Epilepticus Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ceribell, Inc.
- Decided: May 23, 2023 after 182 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K830295 (1983). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191301: Ceribell Pocket EEG Device, Ceribell, Inc. (2019) Summary page 4.

## Most influential descendants
- K240993: encevis (2.1) (2024), 2 descendants of its own
- K261712: Ceribell EEG Analysis Software (2026), 0 descendants of its own
- K260998: Ceribell Neurology Review Software (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K223504
Methodology: https://510kreport.com/methodology