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. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on May 8, 2017 as substantially equivalent to K830295 (Oxford Medilog, Inc., 1983) after a 91-day review. Its family tree reaches back 1 generation to 1983. 25 later devices descend from it.
- Decided
- May 8, 2017
- Review
- 91 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830295 (1983). 25 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- This deviceK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- Descendant · cites it directly · 9 of its ownK183529 AE-120A EEG Head SetNihon Kohden Corporation · 2019
- Descendant · cites it directly · 8 of its ownK191301 Ceribell Pocket EEG DeviceCeribell, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK202334 NeuronauteBioserenity Sas · 2020
- Descendant · 2 generations on · 3 of its ownK223504 Ceribell Status Epilepticus MonitorCeribell, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK203827 REMIEpitel, Inc. · 2021
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K183529AE-120A EEG Head SetNihon Kohden Corporation · 2019 · cites it directly9descendants
- K191301Ceribell Pocket EEG DeviceCeribell, Inc. · 2019 · cites it directly8descendants
- K202334NeuronauteBioserenity Sas · 2020 · 2 generations on4descendants
- K223504Ceribell Status Epilepticus MonitorCeribell, Inc. · 2023 · 2 generations on3descendants
- K203827REMIEpitel, Inc. · 2021 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| 0 (this device) | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| +1 | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 | — |
| +1 | K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019 | — |
| +2 | K202334 | Neuronaute | Bioserenity Sas | 2020 | — |
| +2 | K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | 2023 | — |
| +1 | K203827 | REMI | Epitel, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 OMC? 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 OMC device
- #1 K251550 NX01 (NX01)score 13.1 · 10 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 |
|---|---|---|---|
| * | K830295 | Medilog 9000 SystemSummary page 4…Electroencephalograph (21CFR 882.1400) Device Class: II Product Code: OMC Predicate Device: Oxford Medilog 9000 EEG System, K830295 Date Prepared: February 2nd, 2017 Device Description: The Ceribell Pocket EEG Device (subject) is a portable 8-channel EEG moni… | 1983 |
What descends from it? (25)
See all 257 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?
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OMC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMC
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMC
No recall names OMC since 2007.
Adverse event reports per year · OMC
2in 2025
MAUDE reports naming product code OMC, 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 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 3 | 56 | 0 | 2 |
| 2025 | 3 | 172 | 0 | 2 |
| 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 does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170363: 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/K170363
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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