Cleared Traditional

K171459 - Ceribell Instant EEG Headband (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171459 · Ceribell, Inc. · Neurology device
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Aug 2017
Decision
95d
Days
Class 2
Risk

K171459 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 21, 2017 after a review of 95 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K171459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2017
Decision Date August 21, 2017
Days to Decision 95 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 148d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 433
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K171459.
Tutamen Self Adhesive Electrodes
K252439 · Dongguan Tutamen Metalwork Co., Ltd. · May 2026
myosmart. (13E522)
K253256 · Otto Bock Healthcare Products GmbH · Apr 2026
Ceribell Brain Monitor Headband
K260363 · Ceribell, Inc. · Apr 2026
Remote Wave Electrode (AE03-50)
K260453 · Bionit Labs Srl · Mar 2026
Ceribell Instant EEG Headset
K254033 · Ceribell, Inc. · Feb 2026
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K251381 · Ceribell, Inc. · Oct 2025