Cleared Traditional

MONITRODE (K903491) - FDA 510(k) Clearance

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

K903491 · Lleventon · Cardiovascular device
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Dec 1990
Decision
136d
Days
Class 2
Risk

K903491 is an FDA 510(k) clearance for the MONITRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Lleventon (Spain, ES). The FDA issued a Cleared decision on December 17, 1990 after a review of 136 days - within the typical 510(k) review window.

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 Lleventon devices

Submission Details

510(k) Number K903491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date December 17, 1990
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 125d · This submission: 136d
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 24
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K903491.
MACTRODE 3
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K921164 · Medtronic Vascular · Mar 1993
MODEL 1850 ELECTRODE
K903918 · Medtronic Vascular · Oct 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · 3M Company · Jul 1990
RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989