Cleared Traditional

K896766 - TD-28 DISPOSABLE ELECTRODE

K896766 is the FDA 510(k) clearance for TD-28 DISPOSABLE ELECTRODE by Med USA. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K896766 · Med USA · Neurology device
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Mar 1990
Decision
103d
Days
Class 2
Risk

K896766 is an FDA 510(k) clearance for the TD-28 DISPOSABLE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Med USA (East Fairfield, US). The FDA issued a Cleared decision on March 14, 1990 after a review of 103 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 Med USA devices

Submission Details

510(k) Number K896766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date March 14, 1990
Days to Decision 103 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 148d · This submission: 103d
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 107
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K896766.
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K911069 · Conmedcorp · Jul 1991
TENZCARE ELECTRODE 6862
K893793 · 3M Company · Nov 1989
STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
K881749 · Medtronic Vascular · Jul 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
K875284 · Medtronic Vascular · Jan 1988