510(k) · Cleared
ClearedCeribell EEG Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceribell, Inc. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Sep 16, 2026 as substantially equivalent to K240993 (Ait Austrian Institute of Technology GmbH, 2024) after a 117-day review. Its family tree reaches back 5 generations to 1983.
- Decided
- Sep 16, 2026
- Review
- 117 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K830295 (1983). 9 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 deviceK261712 Ceribell EEG Analysis 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) | K261712 | Ceribell EEG Analysis 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 |
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 OLT? 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 OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 12 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 |
|---|---|---|---|
| * | K240993 | encevis (2.1)Summary page 5…re Classification: Electroencephalograph (21 CFR 882.1400) Device Class: II Product Code: OLT, OMA 3. PREDICATE DEVICES encevis, K240993 4. DEVICE DESCRIPTION The Ceribell EEG Analysis Software is intended for analyzing EEG data acquired from Ceribell EEG record… | 2024 |
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 9 ancestors has a recall.
- 1 other device also cites its predicate K240993.
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
The Ceribell EEG Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid 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 included calculation and display of a set of quantitative measures is intended to monitor and analyze the EEG…
Read the full statement (110 words)
The Ceribell EEG Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid 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 included calculation and display of a set of quantitative measures is intended to monitor and analyze the EEG waveform. These include frequency band metrics and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.
The included aEEG functionality is intended to monitor the state of the brain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261712: Ceribell EEG Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261712
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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