Cleared Traditional

NEUROTRAC (K823116) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823116 · Interspec, Inc. · Neurology device
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Dec 1982
Decision
47d
Days
Class 2
Risk

K823116 is an FDA 510(k) clearance for the NEUROTRAC. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Interspec, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1982 after a review of 47 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 Interspec, Inc. devices

Submission Details

510(k) Number K823116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1982
Decision Date December 07, 1982
Days to Decision 47 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 148d · This submission: 47d
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 43
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K823116.
NEUROFAX 7310 SERIES (EEG)
K854663 · Nihon Kohden America, Inc. · Aug 1986
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
ELECTROENCEPHALOGRAPH
K823140 · Nihon Kohden America, Inc. · Dec 1982
ELECTROENCEPHALOGRAPHS EEG-5208,5210
K820066 · Nihon Kohden America, Inc. · Feb 1982
MODEL EEG 4221
K802887 · Nihon Kohden America, Inc. · Dec 1980