Cleared Traditional

K261712 - Ceribell EEG Analysis Software

K261712 is an FDA 510(k) clearance for Ceribell EEG Analysis Software, manufactured by Ceribell, Inc.. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K261712 · Ceribell, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
117d
Days
Class 2
Risk

K261712 is an FDA 510(k) clearance for the Ceribell EEG Analysis Software. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 16, 2026 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ceribell, Inc. devices

FDA 510(k) Submission Details - K261712

510(k) Number K261712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2026
Decision Date September 16, 2026
Days to Decision 117 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 149d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OLT Non-normalizing Quantitative Electroencephalograph Software

All 39
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K261712.
Pascall Sensor Unit (PSU1)
K254213 · Pascall Systems, Inc. · Aug 2026
HippoMind (v1.0)
K251881 · Hippoclinic · Dec 2025
EEG-1260A Neurofax System (EEG-1260A)
K251366 · Nihon Kohden Corporation · Oct 2025
VEEGix EEG System
K240593 · Neuroservo, Inc. · Aug 2024
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254 · Neurosoft , Ltd. · Nov 2022
Wireless EEG System
K213299 · Pascall Systems, Inc. · May 2022