Cleared Traditional

K053386 - XLTEK EMU40 EEG HEADBOX, MODEL PK1072

K053386 is an FDA 510(k) clearance for XLTEK EMU40 EEG HEADBOX, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K053386 · Excel Tech. , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
137d
Days
Class 2
Risk

K053386 is an FDA 510(k) clearance for the XLTEK EMU40 EEG HEADBOX, MODEL PK1072. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on April 21, 2006 after a review of 137 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K053386

510(k) Number K053386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date April 21, 2006
Days to Decision 137 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
12d faster than avg
Panel avg: 149d · This submission: 137d
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 188
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K053386.
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K053386 · XLTEK EMU40 EEG HEADBOX, MODEL PK1072
Download PDF FDA Summary Excel Tech. , Ltd.