Cleared Traditional

K170363 - Ceribell Pocket EEG Device

K170363 is an FDA 510(k) clearance for Ceribell Pocket EEG Device, manufactured by Ceribell, Inc.. The device is a Class 2 Neurology device with product code OMC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K170363 · Ceribell, Inc. · Neurology device
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May 2017
Decision
91d
Days
Class 2
Risk

K170363 is an FDA 510(k) clearance for the Ceribell Pocket EEG Device. Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Ceribell, Inc. (Mountainview, US). The FDA issued a Cleared decision on May 8, 2017 after a review of 91 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 - K170363

510(k) Number K170363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2017
Decision Date May 08, 2017
Days to Decision 91 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
57d faster than avg
Panel avg: 148d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMC Device Classification - Class 2, Special Controls

Product Code OMC Reduced- Montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes
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 - OMC Reduced- Montage Standard Electroencephalograph

All 14
Devices cleared under the same product code (OMC) and FDA review panel - the closest regulatory comparables to K170363.
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