Cleared Abbreviated

Ceribell Instant EEG Headcap (K223086) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K223086 · Ceribell, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
173d
Days
Class 2
Risk

K223086 is an FDA 510(k) clearance for the Ceribell Instant EEG Headcap. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Ceribell, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 22, 2023 after a review of 173 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ceribell, Inc. devices

Submission Details

510(k) Number K223086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date March 22, 2023
Days to Decision 173 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 148d · This submission: 173d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 97
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K223086.
Conductive Silicone Rubber Electrode
K231167 · Guangzhou Xinbo Electronic Co., Ltd. · Aug 2023
Ceribell Instant EEG Headband
K232052 · Ceribell, Inc. · Aug 2023
Starly pad
K221589 · Shenzhen Xingyuanli Technology Co., Ltd. · Mar 2023
Motive™ Electrode
K230533 · Cymedica Orthopedics, Inc. · Mar 2023
DeltaScan Patch
K222671 · Prolira B.V. · Feb 2023
Garment Electrodes
K222863 · Tone-A-Matic International, Inc. · Feb 2023