Cleared Special

K014147 - 80 CHANNEL EEG

K014147 is an FDA 510(k) clearance for 80 CHANNEL EEG, manufactured by Xltek. The device is a Class 2 Neurology device with product code GWQ cleared through the Special 510(k) pathway after a 27-day FDA review.

K014147 · Xltek · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
27d
Days
Class 2
Risk

K014147 is an FDA 510(k) clearance for the 80 CHANNEL EEG. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Xltek (Oakville, CA). The FDA issued a Cleared decision on January 14, 2002 after a review of 27 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.

FDA 510(k) Submission Details - K014147

510(k) Number K014147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2001
Decision Date January 14, 2002
Days to Decision 27 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
122d faster than avg
Panel avg: 149d · This submission: 27d
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 188
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K014147.
EPOCH XP NEUROLOGICAL WORKSTATION
K022785 · Axon Systems, Inc. · Oct 2002
96 CHANNEL EEG HEADBOX MODEL EMU96
K021599 · Excel Tech. , Ltd. · Aug 2002
84 CHANNEL EEG
K014146 · Xltek · Jan 2002
PAM-RL
K010997 · Individual Monitoring Systems, Inc. · Oct 2001
GEODESIC EEG SYSTEM, MODEL 200
K012079 · Electrical Geodesics, Incorporated · Sep 2001
UNIQUE AMBULATORY EEG
K010697 · Axon Systems, Inc. · Jun 2001
K014147 · 80 CHANNEL EEG
Download PDF FDA Summary Xltek