Cleared Traditional

K863369 - MEL-16-1

K863369 is the FDA 510(k) clearance for MEL-16-1 by Tdk Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 83
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K863369.
S&W ELECTRODE TYPES 888, 844, 988 AND 944
K864586 · S & W Medico Teknik · 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
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246 · Conmedcorp · Aug 1986
FOAM ECG ELECTRODES
K852177 · Clinical Data, Inc. · Aug 1985