Cleared Traditional

K883643 - TDK ECG ELECTRODE

K883643 is the FDA 510(k) clearance for TDK ECG ELECTRODE by Tdk Corp.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K883643 · Tdk Corp. · Cardiovascular device
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Nov 1988
Decision
86d
Days
Class 2
Risk

K883643 is an FDA 510(k) clearance for the TDK ECG ELECTRODE, MEL-10L. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Tdk Corp. (272 01, Japan, JP). The FDA issued a Cleared decision on November 17, 1988 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tdk Corp. devices

Submission Details

510(k) Number K883643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1988
Decision Date November 17, 1988
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
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 K883643.
M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
K884984 · S & W Medico Teknik · Mar 1989
POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
K885262 · Valleylab, Inc. · Jan 1989
BARD TAB ECG MONITORING ELECTRODE
K890103 · C.R. Bard, Inc. · Jan 1989
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064 · C.R. Bard, Inc. · Oct 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
K874421 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D
K874422 · Hewlett-Packard Co. · Jan 1988