Cleared Traditional

K903491 - MONITRODE

K903491 is an FDA 510(k) clearance for MONITRODE, manufactured by Lleventon. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 136-day FDA review.

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

FDA 510(k) Submission Details - K903491

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.

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 195
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K903491.
RT40 RADIO TRANSLUCENT
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K903918 · Medtronic Vascular · Oct 1990
SILVER MACTRODE
K902176 · Marquette Electronics, Inc. · Sep 1990
ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH
K902738 · Labeltape Meditect, Inc. · Sep 1990