Cleared Traditional

K882904 - TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5

K882904 is an FDA 510(k) clearance for TDK ELECTRODE MEL-20-1, 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 85-day FDA review.

K882904 · Tdk Corp. · Cardiovascular device
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Oct 1988
Decision
85d
Days
Class 2
Risk

K882904 is an FDA 510(k) clearance for the TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5. 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 October 5, 1988 after a review of 85 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

FDA 510(k) Submission Details - K882904

510(k) Number K882904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1988
Decision Date October 05, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
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 190
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K882904.
POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
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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
SYNCOR (R) MODEL S-801 ECG ELECTRODE
K882216 · Lectec Corp. · Jul 1988
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)
K872866 · Labeltape Meditect, Inc. · Jan 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
K874421 · Hewlett-Packard Co. · Jan 1988