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
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 148d · 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 97
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K163163.
Natus Quantum
K180181 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Feb 2018
NeuroEEG
K173460 · Memory MD, Inc. · Feb 2018
Micromed BRAIN QUICK system
K171384 · Micromed S.P.A. · Feb 2018
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K113117 · Nihon Kohden America, Inc. · Mar 2012
ENTROPY EASYFIT SENSOR
K103129 · Ge Healthcare · Jul 2011
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
K053386 · Excel Tech. , Ltd. · Apr 2006