Cleared Traditional

K162681 - Enobio Wireless EEG

K162681 is an FDA 510(k) clearance for Enobio Wireless EEG, manufactured by Neuroelectrics Barcelona S.L.U.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K162681 · Neuroelectrics Barcelona S.L.U. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
249d
Days
Class 2
Risk

K162681 is an FDA 510(k) clearance for the Enobio Wireless EEG. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Neuroelectrics Barcelona S.L.U. (Barcelona, ES). The FDA issued a Cleared decision on June 2, 2017 after a review of 249 days - an extended review cycle.

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 Neuroelectrics Barcelona S.L.U. devices

FDA 510(k) Submission Details - K162681

510(k) Number K162681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2016
Decision Date June 02, 2017
Days to Decision 249 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
100d slower than avg
Panel avg: 149d · This submission: 249d
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 Peers - GWQ Full-montage Standard Electroencephalograph

All 155
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K162681.
eVox System
K171781 · Evoke Neuroscience, Inc. · Dec 2017
Nihon Kohden Wireless Input Unit WEE-1200
K171124 · Nihon Kohden Corporation · Aug 2017
ElectroTek
K170441 · Mobilemedtek · Jun 2017
XLTEK EMU40EX EEG Headbox
K163163 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Dec 2016
Trex_HD
K162595 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Nov 2016
Discovery 24
K150498 · Brainmaster Technologies, Inc. · Jan 2016