Ceribell, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Ceribell, Inc.” (first 2017, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 118 days. Since 2017 the median was 118 days, against 145 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 93 |
| 2018 | 0 | — |
| 2019 | 1 | 120 |
| 2020 | 0 | — |
| 2021 | 1 | 166 |
| 2022 | 0 | — |
| 2023 | 3 | 173 |
| 2024 | 0 | — |
| 2025 | 4 | 174 |
| 2026 | 5 | 89 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ceribell, Inc. took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 7 | 7 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 5 | 5 |
| OMC | Reduced- Montage Standard Electroencephalograph | 2 | 2 |
| NCG | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid | 1 | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 | 1 |
Review panels
- Neurology (16)
Most recent Ceribell, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261712 | Ceribell EEG Analysis Software | OLT | 2026-09-16 | 117 |
| K261101 | Ceribell Monitor | OMC | 2026-06-30 | 89 |
| K260998 | Ceribell Neurology Review Software | OMB | 2026-06-24 | 90 |
| K260363 | Ceribell Brain Monitor Headband | GXY | 2026-04-03 | 58 |
| K254033 | Ceribell Instant EEG Headset | GXY | 2026-02-09 | 55 |
| K251936 | Ceribell Delirium Monitor System | NCG | 2025-12-08 | 167 |
| K252070 | Ceribell Infant Seizure Detection Software | OMB | 2025-11-21 | 143 |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | GXY | 2025-10-31 | 182 |
| K241589 | Ceribell Seizure Detection Software | OMB | 2025-04-09 | 310 |
| K232052 | Ceribell Instant EEG Headband | GXY | 2023-08-08 | 29 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ceribell, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Ceribell, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07485244: EEG Abnormalities in Adult ICU Patients With High Risk of Delirium (Recruiting, started 2026-04-16)
- NCT04962815: Ceribell Delirium Data Collection Study (Recruiting, started 2021-11-10)
- NCT03534258: Does Use of Rapid Response EEG Impact Clinical Decision Making (Completed, started 2018-04-30)
SEC filings
Ceribell, Inc. (CBLL): EDGAR filings, CIK 1861107. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ceribell, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Ceribell, Inc.” (first 2017, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ceribell, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ceribell, Inc. is 118 days. Since 2017: 118 days, versus 145 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ceribell, Inc.?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 7); OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph, 5); OMC (Reduced- Montage Standard Electroencephalograph, 2).
Next steps
- See all 16 Ceribell, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXY, Ceribell, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.