# Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 30/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261712 |
| Device | Ceribell EEG Analysis Software |
| Applicant | Ceribell, Inc. |
| Specialty / panel | Neurology |
| Product code | OLT |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-22 |
| Decision date | 2026-09-16 |
| Review time (days) | 117 |
| Third-party review | No |
| Applicant location | Sunnyvale, CA, US |

## Why this score
- Fast 117-day review: this device is a strong predicate for similar products.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261712). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.