Cleared Traditional

K902550 - EEG-5400 SERIES

K902550 is an FDA 510(k) clearance for EEG-5400 SERIES, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K902550 · Nihon Kohden America, Inc. · Neurology device
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Mar 1991
Decision
286d
Days
Class 2
Risk

K902550 is an FDA 510(k) clearance for the EEG-5400 SERIES. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on March 19, 1991 after a review of 286 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K902550

510(k) Number K902550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1990
Decision Date March 19, 1991
Days to Decision 286 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 148d · This submission: 286d
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 96
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K902550.
PHOENIX DIGITAL EEG SYSTEM
K911229 · Dantec Medical, Inc. · Sep 1991
HORIZON 2000 EEG MONITORING OPTION
K910945 · Mennen Medical, Inc. · Aug 1991
MENTOR EEG SYSTEM
K904763 · Oxford Medilog, Inc. · Apr 1991
EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH
K903004 · Teca, Inc. · Nov 1990
SPACELABS MODEL 90480 EEG MODULE
K896942 · Spacelabs, Inc. · Mar 1990
P460, DG32 ELECTROENCEPHALOGRAPH
K896666 · Teca, Inc. · Feb 1990