Cleared Special

K042150 - XLTEK TREX MODEL#10309

K042150 is the FDA 510(k) clearance for XLTEK TREX MODEL#10309 by Excel Tech. , Ltd.. It is a Class 2 Neurology device (product code GWQ) cleared through the Special 510(k) pathway after a 18-day FDA review.

K042150 · Excel Tech. , Ltd. · Neurology device
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Aug 2004
Decision
18d
Days
Class 2
Risk

K042150 is an FDA 510(k) clearance for the XLTEK TREX MODEL#10309. 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 August 27, 2004 after a review of 18 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 Excel Tech. , Ltd. devices

Submission Details

510(k) Number K042150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2004
Decision Date August 27, 2004
Days to Decision 18 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 148d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 88
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