Cleared Traditional

K833899 - TDK ECG ELECTRODE MEL-08

K833899 is the FDA 510(k) clearance for TDK ECG ELECTRODE MEL-08 by Tdk Corp.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K833899 · Tdk Corp. · Cardiovascular device
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Feb 1984
Decision
88d
Days
Class 2
Risk

K833899 is an FDA 510(k) clearance for the TDK ECG ELECTRODE MEL-08. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Tdk Corp. (Walker, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 88 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 K833899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date February 10, 1984
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K833899.
CANMED 101
K844100 · Medtronic Vascular · Dec 1984
ESOPHOGRAL MULTIPROBE
K832903 · Vital Signs, Inc. · May 1984
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445 · Graphic Controls Corp. · Apr 1984
ADULT MONITORING ELECTOR@@RODE 9431-300
K833695 · Marquette Electronics, Inc. · Jan 1984
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · Quinton, Inc. · Jun 1983
MEDI-TRACE 5' OFFSET ELECTRODE
K822750 · Graphic Controls Corp. · Nov 1982