Cleared Traditional

K950782 - MEDI-TRAC EEG ELECTRODE

K950782 is the FDA 510(k) clearance for MEDI-TRAC EEG ELECTRODE by Graphic Controls Corp.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K950782 · Graphic Controls Corp. · Neurology device
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Jun 1995
Decision
121d
Days
Class 2
Risk

K950782 is an FDA 510(k) clearance for the MEDI-TRAC EEG ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Buafflo, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Graphic Controls Corp. devices

Submission Details

510(k) Number K950782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date June 22, 1995
Days to Decision 121 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 148d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 152
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K950782.
EEG ELECTRODES
K962283 · Teca, Inc. · Dec 1996
DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
K944314 · Bio-Logic Systems Corp. · Jan 1996
NEUROLOGICAL DIAGNOSTIC DEVICES
K943449 · Henley Intl. · Nov 1995
RICH-MAR CARBON ELECTRODES
K950491 · Rich-Mar Corp. · Mar 1995
DISPOSABLE CUTANEOUS ELECTRODES
K941799 · Bio-Logic Systems Corp. · Feb 1995
EEG CUP ELECTRODE
K933808 · Cadwell Laboratories, Inc. · Dec 1994