Cleared Traditional

K904269 - NEUROSEARCH-24 OR NRS-24

K904269 is an FDA 510(k) clearance for NEUROSEARCH-24 OR NRS-24, manufactured by Lexicor Medical Technology, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K904269 · Lexicor Medical Technology, Inc. · Neurology device
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Jun 1991
Decision
259d
Days
Class 2
Risk

K904269 is an FDA 510(k) clearance for the NEUROSEARCH-24 OR NRS-24. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Lexicor Medical Technology, Inc. (Boulder, US). The FDA issued a Cleared decision on June 4, 1991 after a review of 259 days - an extended review cycle.

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.

View all Lexicor Medical Technology, Inc. devices

FDA 510(k) Submission Details - K904269

510(k) Number K904269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1990
Decision Date June 04, 1991
Days to Decision 259 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 148d · This submission: 259d
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 138
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K904269.
NEUROFAX EEG 5532
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HORIZON 2000 EEG MONITORING OPTION
K910945 · Mennen Medical, Inc. · Aug 1991
MENTOR EEG SYSTEM
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EEG-5400 SERIES
K902550 · Nihon Kohden America, Inc. · Mar 1991
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K903004 · Teca, Inc. · Nov 1990