Cleared Traditional

TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5 (K882904) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 328
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K882904.
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