510(k) · Cleared
ClearedCeribell Status Epilepticus Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceribell, Inc. · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on May 23, 2023 as substantially equivalent to K191301 (Ceribell, Inc., 2019) after a 182-day review. Its family tree reaches back 3 generations to 1983. 3 later devices descend from it.
- Decided
- May 23, 2023
- Review
- 182 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K830295 (1983). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 2 generations backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- 1 generation backK191301 Ceribell Pocket EEG DeviceCeribell, Inc. · 2019
- This deviceK223504 Ceribell Status Epilepticus MonitorCeribell, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK240993 encevis (2.1)Ait Austrian Institute of Technology GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK261712 Ceribell EEG Analysis SoftwareCeribell, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260998 Ceribell Neurology Review SoftwareCeribell, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −2 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| −1 | K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019 | — |
| 0 (this device) | K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | 2023 | — |
| +1 | K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | 2024 | — |
| +2 | K261712 | Ceribell EEG Analysis Software | Ceribell, Inc. | 2026 | — |
| +2 | K260998 | Ceribell Neurology Review Software | Ceribell, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMB device
- #1 K240993 encevis (2.1)score 15.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191301 | Ceribell Pocket EEG DeviceSummary page 4…II; 21 CFR 882.1400 Product Code: OMB OMB Device: Automatic Event Detection Software for Full-Montage Electroencephalograph Predicate Device: K191301 Ceribell Pocket EEG Device 882.1400, OMB (automatic event detection software for full-montage electroencephalograph), OMC, GWQ D… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240993 | encevis (2.1) | 2024 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K240993 (Ait Austrian Institute of Technology GmbH, 2024) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K191301.
How does its category compare?
All OMB devicesOMB Automatic Event Detection Software For Full-Montage Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OMB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMB
143in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMB
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMB
6in 2025
MAUDE reports naming product code OMB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 3 | 233 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 108 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 5 | 201 | 0 | 21 |
| 2025 | 5 | 143 | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (173 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223504: Ceribell Status Epilepticus Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223504
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026