Cleared Traditional

K863584 - EM II STRESS TEST ELECTRODE

K863584 is an FDA 510(k) clearance for EM II STRESS TEST ELECTRODE, manufactured by Electromed Intl., Ltd.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K863584 · Electromed Intl., Ltd. · Cardiovascular device
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Dec 1986
Decision
84d
Days
Class 2
Risk

K863584 is an FDA 510(k) clearance for the EM II STRESS TEST ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Electromed Intl., Ltd. (Waltham, US). The FDA issued a Cleared decision on December 8, 1986 after a review of 84 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 Electromed Intl., Ltd. devices

FDA 510(k) Submission Details - K863584

510(k) Number K863584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1986
Decision Date December 08, 1986
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 186
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K863584.
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868 · Hewlett-Packard Co. · Jan 1987
DISPOSABLE ECG MONITORING ELECTRODE
K863904 · Clinical Data, Inc. · Jan 1987
EM II DISPOSABLE ELECTRODE
K863540 · Electromed Intl., Ltd. · Dec 1986
PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE
K863366 · Labeltape Meditect, Inc. · Nov 1986
EM III DISPOSABLE ELECTRODE
K863845 · Electromed Intl., Ltd. · Nov 1986
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246 · Conmedcorp · Aug 1986