Cleared Traditional

K170138 - NEURONAUTE

K170138 is an FDA 510(k) clearance for NEURONAUTE, manufactured by Bioserenity. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K170138 · Bioserenity · Neurology device
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Dec 2017
Decision
343d
Days
Class 2
Risk

K170138 is an FDA 510(k) clearance for the NEURONAUTE. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Bioserenity (Paris, FR). The FDA issued a Cleared decision on December 26, 2017 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bioserenity devices

FDA 510(k) Submission Details - K170138

510(k) Number K170138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2017
Decision Date December 26, 2017
Days to Decision 343 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
194d slower than avg
Panel avg: 149d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-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 Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 Consultant

Voisin Consulting Inc., Life Sciences
Esin YESILALAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWQ Full-montage Standard Electroencephalograph

All 157
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K170138.
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K180181 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Feb 2018
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K173460 · Memory MD, Inc. · Feb 2018
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K171384 · Micromed S.P.A. · Feb 2018
eVox System
K171781 · Evoke Neuroscience, Inc. · Dec 2017
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K171124 · Nihon Kohden Corporation · Aug 2017
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K170441 · Mobilemedtek · Jun 2017