Cleared Traditional

K903918 - MODEL 1850 ELECTRODE

K903918 is the FDA 510(k) clearance for MODEL 1850 ELECTRODE by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K903918 · Medtronic Vascular · Cardiovascular device
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Oct 1990
Decision
68d
Days
Class 2
Risk

K903918 is an FDA 510(k) clearance for the MODEL 1850 ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Medtronic Vascular (Haverhill, US). The FDA issued a Cleared decision on October 31, 1990 after a review of 68 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 Medtronic Vascular devices

Submission Details

510(k) Number K903918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1990
Decision Date October 31, 1990
Days to Decision 68 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 125d · This submission: 68d
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 80
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K903918.
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE
K930312 · 3M Health Care, Ltd. · Sep 1993
3M RED DOT 2330 RESTING EKG ELECTRODE
K932454 · 3M Health Care, Ltd. · Aug 1993
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · Medtronic Vascular · Mar 1993
SILVER MACTRODE
K902176 · Marquette Electronics, Inc. · Sep 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · 3M Company · Jul 1990