Cleared Traditional

K952176 - DISPOSABLE NEUROLOGY ELECTRODES NEUROLI...

K952176 is the FDA 510(k) clearance for DISPOSABLE NEUROLOGY ELECTRODES NEUROLI... by Medicotest, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K952176 · Medicotest, Inc. · Neurology device
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Sep 1995
Decision
140d
Days
Class 2
Risk

K952176 is an FDA 510(k) clearance for the DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medicotest, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 25, 1995 after a review of 140 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 Medicotest, Inc. devices

Submission Details

510(k) Number K952176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date September 25, 1995
Days to Decision 140 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 148d · This submission: 140d
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 153
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K952176.
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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
MEDI-TRAC EEG ELECTRODE
K950782 · Graphic Controls Corp. · Jun 1995
RICH-MAR CARBON ELECTRODES
K950491 · Rich-Mar Corp. · Mar 1995
DISPOSABLE CUTANEOUS ELECTRODES
K941799 · Bio-Logic Systems Corp. · Feb 1995