510(k) · Cleared
ClearedCeribell Neurology Review Software
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 Jun 24, 2026 as substantially equivalent to K240993 (Ait Austrian Institute of Technology GmbH, 2024) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1983.
- Decided
- Jun 24, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K830295 (1983). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 4 generations backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- 3 generations backK191301 Ceribell Pocket EEG DeviceCeribell, Inc. · 2019
- 2 generations backK223504 Ceribell Status Epilepticus MonitorCeribell, Inc. · 2023
- 1 generation backK240993 encevis (2.1)Ait Austrian Institute of Technology GmbH · 2024
- This deviceK260998 Ceribell Neurology Review SoftwareCeribell, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −4 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| −3 | K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019 | — |
| −2 | K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | 2023 | — |
| −1 | K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | 2024 | — |
| 0 (this device) | K260998 | Ceribell Neurology Review Software | Ceribell, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K240993 | encevis (2.1)Summary page 5…ograph Classification: Electroencephalograph (21 CFR 882.1400) Device Class: II Product Code: OMB, OLT 3. PREDICATE DEVICES Primary: encevis, K240993 Secondary: autoSCORE, K243743 4. DEVICE DESCRIPTION The Ceribell Neurology Review Software is intended for analyzing EEG data… | 2024 |
| * | K243743 | autoSCORE (V 2.0.0)Summary page 5…Electroencephalograph (21 CFR 882.1400) Device Class: II Product Code: OMB, OLT 3. PREDICATE DEVICES Primary: encevis, K240993 Secondary: autoSCORE, K243743 4. DEVICE DESCRIPTION The Ceribell Neurology Review Software is intended for analyzing EEG data acquired from legally marketed… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 43 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K240993.
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. 2026, 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 Neurology Review Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified clinical practitioners who will exercise professional judgment in using the information. The Artifact Reduction component is intended to reduce artifact in EEG recordings. The Artifact…
Read the full statement (166 words)
The Ceribell Neurology Review Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified clinical practitioners who will exercise professional judgment in using the information.
The Artifact Reduction component is intended to reduce artifact in EEG recordings. The Artifact Reduction component does not remove the entire artifact signal and may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified clinical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.
The Epileptiform Abnormality Detection component is intended to mark previously acquired sections of the patient’s EEG recordings that may correspond to epileptiform abnormalities in order to assist qualified clinical practitioners in the assessment of EEG traces. The Epileptiform Abnormality Detection component is intended to be used in patients at least one year old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260998: Ceribell Neurology Review Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260998
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026