Cleared Traditional

K850259 - ELECTROENCEPHALOGRAPH EEG

K850259 is the FDA 510(k) clearance for ELECTROENCEPHALOGRAPH EEG by Nicolet Biomedical Instruments. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K850259 · Nicolet Biomedical Instruments · Neurology device
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Apr 1985
Decision
79d
Days
Class 2
Risk

K850259 is an FDA 510(k) clearance for the ELECTROENCEPHALOGRAPH EEG. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Madison, US). The FDA issued a Cleared decision on April 11, 1985 after a review of 79 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nicolet Biomedical Instruments devices

Submission Details

510(k) Number K850259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1985
Decision Date April 11, 1985
Days to Decision 79 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 148d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 89
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K850259.
MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM
K860456 · Oxford Medilog, Inc. · Aug 1986
DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
K854268 · Del Mar Avionics · Mar 1986
BUSHEL OFF-HEAD PREAMPLIFIER
K850418 · Oxford Medilog, Inc. · Jun 1985
DEL MAR AVIONICS 5509 NEURO-SCANNER
K841653 · Del Mar Avionics · Dec 1984
EEG-4300 W/OPTINAL ACCESS. EEG 4314 &
K842714 · Nihon Kohden America, Inc. · Sep 1984
EEG 42/2P ELECTRO ENCEPHALOGRAPH
K831324 · Nihon Kohden America, Inc. · May 1983