510(k) · Cleared
ClearedCeribell Pocket EEG Device
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 Sep 11, 2019 as substantially equivalent to K170363 (Ceribell, Inc., 2017) and 1 other predicate after a 120-day review. Its family tree reaches back 2 generations to 1983. 8 later devices descend from it.
- Decided
- Sep 11, 2019
- Review
- 120 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K830295 (1983). 3 ancestors in all. 8 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 1 generation backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- This deviceK191301 Ceribell Pocket EEG DeviceCeribell, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK223504 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 · cites it directly · 1 of its ownK241589 Ceribell Seizure Detection SoftwareCeribell, Inc. · 2025
- 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K223504Ceribell Status Epilepticus MonitorCeribell, Inc. · 2023 · cites it directly3descendants
- K240993encevis (2.1)Ait Austrian Institute of Technology GmbH · 2024 · cites it directly2descendants
- K241589Ceribell Seizure Detection SoftwareCeribell, Inc. · 2025 · cites it directly1descendant
- K261712Ceribell EEG Analysis SoftwareCeribell, Inc. · 2026 · 2 generations on0descendants
- K260998Ceribell Neurology Review SoftwareCeribell, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −1 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| 0 (this device) | K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019 | — |
| +1 | K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | 2023 | — |
| +1 | K240993 | encevis (2.1) | Ait Austrian Institute of Technology GmbH | 2024 | — |
| +1 | K241589 | Ceribell Seizure Detection Software | Ceribell, Inc. | 2025 | — |
| +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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K170363 | Ceribell Pocket EEG DeviceSummary page 4…on Software for Full-Montage Electroencephalograph Additional Pro Codes: OMC, GWQ (full-montage standard electroencephalograph) Predicate Device Primary Predicate: K170363 Ceribell Pocket EEG Device 882.1400, OMC (reduced- montage standard electroenceph… | 2017 |
| * | K151929 | Persyst 13 (P13) Eeg Review and Analysis SoftwareSummary page 4…Ceribell Pocket EEG Device 882.1400, OMC (reduced- montage standard electroencephalograph), GWQ Secondary Predicate K151929 Persyst 13 (P13) 882.1400, OMB, OLT (non-normalizing quantitative electroencephal… | 2015 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 36 years and passes through 2 companies; a new generation was cleared every 34.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K223504 (Ceribell, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K170363.
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. 2019, 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 Pocket EEG Device is intended to record and store EEG signals, and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device is intended to be used in a professional healthcare facility environment. Additionally, the EEG Recording Viewer Software component of the Pocket EEG Device incorporates a Seizure Detection…
Read the full statement (225 words)
The Ceribell Pocket EEG Device is intended to record and store EEG signals, and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.
Additionally, the EEG Recording Viewer Software component of the Pocket EEG Device incorporates a Seizure Detection component that is intended to mark previously acquired sections of EEG recordings in patients greater than or equal to 18 years of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection component provides notifications to the user when detected seizure prevalence is “Frequent,” “Abundant,” or “Continuous,” per the definitions of the American Clinical Neurophysiology Society Guideline 14. Notifications include an on-screen display on the Pocket EEG Device and the optional sending of an e-mail message to a clinician. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.
The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191301: Ceribell Pocket EEG Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191301
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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