Cleared Traditional

K171459 - Ceribell Instant EEG Headband

K171459 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 95-day FDA review.

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

FDA 510(k) Submission Details - K171459

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.

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 185
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K171459.
S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
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Electrodes with snap / Electrodes with pigtail
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Electrodes with silver conductive
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BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
K143506 · Covidien · Apr 2015
GARMENT ELECTRODES
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DYNATRON PELTIER THERMOSTIM PROBE
K132057 · Dynatronics Corp. · Jan 2014