Cleared Traditional

K873535 - NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM

K873535 is the FDA 510(k) clearance for NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM by Nicolet Biomedical Instruments. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K873535 · Nicolet Biomedical Instruments · Neurology device
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Oct 1987
Decision
55d
Days
Class 2
Risk

K873535 is an FDA 510(k) clearance for the NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM. 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 October 26, 1987 after a review of 55 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 K873535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date October 26, 1987
Days to Decision 55 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 148d · This submission: 55d
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 K873535.
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MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
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AMBULATORY EEG PLAYBACK
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MODEL 5000 AMBULATORY MONITORING SYSTEM
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NEUROFAX 7310 SERIES (EEG)
K854663 · Nihon Kohden America, Inc. · Aug 1986