510(k) · Cleared
ClearedCeribell Monitor
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 Jun 30, 2026 as substantially equivalent to K170363 (Ceribell, Inc., 2017) and 1 other predicate after an 89-day review. Its family tree reaches back 5 generations to 1983.
- Decided
- Jun 30, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K830295 (1983). 7 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 backK183529 AE-120A EEG Head SetNihon Kohden Corporation · 2019
- 2 generations backK202334 NeuronauteBioserenity Sas · 2020
- 1 generation backK231366 Neuronaute PlusBioserenity Sas · 2023
- This deviceK261101 Ceribell MonitorCeribell, 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 | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 | — |
| −2 | K202334 | Neuronaute | Bioserenity Sas | 2020 | — |
| −1 | K231366 | Neuronaute Plus | Bioserenity Sas | 2023 | — |
| 0 (this device) | K261101 | Ceribell Monitor | Ceribell, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 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 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? (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 5…Electroencephalograph (21 CFR 882.1400) Device Class: II Product Code: OMC, GWQ 3. PREDICATE DEVICES Primary: Ceribell Pocket EEG Device, K170363 Secondary: Neuronaute Plus, K231366 4. DEVICE DESCRIPTION The Ceribell Monitor is a portable, full-montage EEG system intended… | 2017 |
| * | K231366 | Neuronaute PlusSummary page 5…82.1400) Device Class: II Product Code: OMC, GWQ 3. PREDICATE DEVICES Primary: Ceribell Pocket EEG Device, K170363 Secondary: Neuronaute Plus, K231366 4. DEVICE DESCRIPTION The Ceribell Monitor is a portable, full-montage EEG system intended to acquire, transmit, display and s… | 2023 |
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 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 7 ancestors has a recall.
- 6 other devices also cite its predicate K170363.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Monitor is intended to acquire, transmit, display and store electroencephalogram (EEG) and optionally electrocardiogram (ECG) and video. The Ceribell Monitor is intended for prescription use in professional healthcare facilities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261101: Ceribell Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261101
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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