510(k) · Cleared
ClearedCeribell Delirium Monitor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceribell, Inc. · NCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Cleared on Dec 8, 2025 as substantially equivalent to K222680 (Prolira B.V., 2023) and 2 other predicates after a 167-day review. Its family tree reaches back 7 generations to 1978.
- Decided
- Dec 8, 2025
- Review
- 167 days
- Class
- Class II
- Product code
- NCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K780045 (1978). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK780045 Electrode CapElectro-Cap Intl., Inc. · 1978
- 6 generations backK071446 Electrode Array CapElectrode Arrays · 2008
- 5 generations backK110223 Waveguard (TM) Eeg CapEemagine Medical Imaging Solutions GmbH · 2011
- 4 generations backK112319 Electro-Cap SystemElectro-Cap Intl., Inc. · 2012
- 3 generations backK200162 Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)Wuhan Greentek Pty, Ltd. · 2020
- 2 generations backK210805 Ceribell Instant EEG HeadbandCeribell, Inc. · 2021
- 1 generation backK232052 Ceribell Instant EEG HeadbandCeribell, Inc. · 2023
- This deviceK251936 Ceribell Delirium Monitor SystemCeribell, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K780045 | Electrode Cap | Electro-Cap Intl., Inc. | 1978 | — |
| −6 | K071446 | Electrode Array Cap | Electrode Arrays | 2008 | — |
| −5 | K110223 | Waveguard (TM) Eeg Cap | Eemagine Medical Imaging Solutions GmbH | 2011 | — |
| −4 | K112319 | Electro-Cap System | Electro-Cap Intl., Inc. | 2012 | — |
| −3 | K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty, Ltd. | 2020 | — |
| −2 | K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2021 | — |
| −1 | K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | 2023 | — |
| 0 (this device) | K251936 | Ceribell Delirium Monitor System | Ceribell, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2000 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 NCG? 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 NCG device
- #1 K222680 DeltaScan Monitorscore 7.8 · 1 generation · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K222680 | DeltaScan MonitorSummary page 5…Name: Neuropsychiatric Interpretive Electroencephalograph Assessment Aid Device Class: II Product Code: NCG 3. Predicate Device: Primary Predicate: K222680: DeltaScan Monitor Secondary Predicates: K191301: Ceribell Pocket EEG Device K232052: Ceribell Instant EEG Headband… | 2023 |
| * | K191301 | Ceribell Pocket EEG DeviceSummary page 5…halograph Assessment Aid Device Class: II Product Code: NCG 3. Predicate Device: Primary Predicate: K222680: DeltaScan Monitor Secondary Predicates: K191301: Ceribell Pocket EEG Device K232052: Ceribell Instant EEG Headband… | 2019 |
| * | K232052 | Ceribell Instant EEG HeadbandSummary page 5…s: II Product Code: NCG 3. Predicate Device: Primary Predicate: K222680: DeltaScan Monitor Secondary Predicates: K191301: Ceribell Pocket EEG Device K232052: Ceribell Instant EEG Headband… | 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 47 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All NCG devicesNCG Neuropsychiatric Interpretative Electroencephalograph Assessment Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NCG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NCG
Too few NCG 510(k)s in any year since 2007 to give a median.
Recalls per year · NCG
No recall names NCG since 2007.
Adverse event reports per year · NCG
No MAUDE report names NCG since 2007.
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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ceribell Delirium Monitor System is intended to analyze features associated with diffuse slowing electroencephalogram (EEG) patterns that may be indicative of delirium. The Ceribell Delirium Monitor software is intended to aid in the screening and monitoring of delirium with clinical assessments in adult patients in critical care settings within hospitals.
The Ceribell Delirium Monitor System analyzes discrete segments of EEG to notify clinicians when EEG patterns associated with delirium are detected while monitoring the patient. Changes in patient condition that are detected by the device should be verified before commencing any interventions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251936 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251936: Ceribell Delirium Monitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251936
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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