Cleared Special

K163163 - XLTEK EMU40EX EEG Headbox

K163163 is an FDA 510(k) clearance for XLTEK EMU40EX EEG Headbox, manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The device is a Class 2 Neurology device with product code GWQ cleared through the Special 510(k) pathway after a 34-day FDA review.

K163163 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
34d
Days
Class 2
Risk

K163163 is an FDA 510(k) clearance for the XLTEK EMU40EX EEG Headbox. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on December 14, 2016 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) devices

FDA 510(k) Submission Details - K163163

510(k) Number K163163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2016
Decision Date December 14, 2016
Days to Decision 34 days
Submission Type Special
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
115d faster than avg
Panel avg: 149d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

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 153
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K163163.
Nihon Kohden Wireless Input Unit WEE-1200
K171124 · Nihon Kohden Corporation · Aug 2017
ElectroTek
K170441 · Mobilemedtek · Jun 2017
Enobio Wireless EEG
K162681 · Neuroelectrics Barcelona S.L.U. · Jun 2017
Trex_HD
K162595 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Nov 2016
Discovery 24
K150498 · Brainmaster Technologies, Inc. · Jan 2016
Mitsar-EEG
K143233 · Mitsar Co., Ltd. · Aug 2015