Cleared Traditional

K863369 - MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES

K863369 is an FDA 510(k) clearance for MEL-16-1, manufactured by Tdk Corp.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K863369 · Tdk Corp. · Cardiovascular device
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Jan 1987
Decision
166d
Days
Class 2
Risk

K863369 is an FDA 510(k) clearance for the MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Tdk Corp. (Chicago, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 166 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Tdk Corp. devices

FDA 510(k) Submission Details - K863369

510(k) Number K863369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1986
Decision Date January 06, 1987
Days to Decision 166 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 125d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 189
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K863369.
TRACETS 2000/ELECTRODES
K863674 · Lectec Corp. · Mar 1987
MEDI-TRACE INFANT ELECTRODE
K864722 · Graphic Controls Corp. · Feb 1987
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868 · Hewlett-Packard Co. · Jan 1987
DISPOSABLE ECG MONITORING ELECTRODE
K863904 · Clinical Data, Inc. · Jan 1987
EM II DISPOSABLE ELECTRODE
K863540 · Electromed Intl., Ltd. · Dec 1986
EM II STRESS TEST ELECTRODE
K863584 · Electromed Intl., Ltd. · Dec 1986