Cleared Traditional

K840465 - Q-MED ELECTRODE

K840465 is the FDA 510(k) clearance for Q-MED ELECTRODE by Qmed, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K840465 · Qmed, Inc. · Cardiovascular device
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Jun 1984
Decision
137d
Days
Class 2
Risk

K840465 is an FDA 510(k) clearance for the Q-MED ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Qmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984 after a review of 137 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 Qmed, Inc. devices

Submission Details

510(k) Number K840465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1984
Decision Date June 19, 1984
Days to Decision 137 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 125d · This submission: 137d
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 K840465.
FOAM ECG ELECTRODES
K852177 · Clinical Data, Inc. · Aug 1985
CANMED 102
K844099 · Medtronic Vascular · Dec 1984
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