Cleared Traditional

K210805 - Ceribell Instant EEG Headband

K210805 is an FDA 510(k) clearance for Ceribell Instant EEG Headband, manufactured by Ceribell, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K210805 · Ceribell, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
166d
Days
Class 2
Risk

K210805 is an FDA 510(k) clearance for the Ceribell Instant EEG Headband. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Ceribell, Inc. (Mountainview, US). The FDA issued a Cleared decision on August 30, 2021 after a review of 166 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 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 - K210805

510(k) Number K210805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2021
Decision Date August 30, 2021
Days to Decision 166 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
18d slower than avg
Panel avg: 148d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 184
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K210805.
Comby EEG Caps
K211315 · Pamel D.O.O · Nov 2021
Adhesive Electrodes
K212191 · Voncare Medical Device Co., Ltd. · Oct 2021
Adhesive Electrode
K210448 · Shaoxing Yingtuo Healthcare Co., Ltd. · Aug 2021
Metallic Fabric Electrodes
K202636 · Guangzhou Xinbo Electronic Co., Ltd. · Aug 2021
Electrode Market Disposable Surface Electrodes
K211839 · Electrode Market Co., Ltd. · Jul 2021
BioWave BioWraps
K203158 · Biowave Corporation · Jul 2021