Cleared Traditional

K853774 - EM ELECTRODE

K853774 is an FDA 510(k) clearance for EM 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 219-day FDA review.

K853774 · Electromed Intl., Ltd. · Cardiovascular device
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Apr 1986
Decision
219d
Days
Class 2
Risk

K853774 is an FDA 510(k) clearance for the EM 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 April 17, 1986 after a review of 219 days - an extended review 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: 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 Electromed Intl., Ltd. devices

FDA 510(k) Submission Details - K853774

510(k) Number K853774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1985
Decision Date April 17, 1986
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
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 K853774.
EUROMED S-601
K862765 · Lectec Corp. · Aug 1986
ECG MONITORING/DEFIBRILLATION ELECTRODE
K854433 · Andover Medical, Inc. · May 1986
EM STRESS ELECTRODE
K860827 · Electromed Intl., Ltd. · May 1986
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
K853038 · Bio-Detek, Inc. · Jan 1986
FOAM ECG ELECTRODES
K852177 · Clinical Data, Inc. · Aug 1985
SYNKARA
K840445 · Lectec Corp. · May 1985