Cleared Traditional

K861246 - PREMIE DISC ECG ELECTRODE W/PREATTACHED...

K861246 is an FDA 510(k) clearance for PREMIE DISC ECG ELECTRODE W/PREATTACHED..., manufactured by Conmedcorp. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K861246 · Conmedcorp · Cardiovascular device
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Aug 1986
Decision
132d
Days
Class 2
Risk

K861246 is an FDA 510(k) clearance for the PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on August 6, 1986 after a review of 132 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.

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FDA 510(k) Submission Details - K861246

510(k) Number K861246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1986
Decision Date August 06, 1986
Days to Decision 132 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
7d slower than avg
Panel avg: 125d · This submission: 132d
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 117
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K861246.
EM II STRESS TEST ELECTRODE
K863584 · 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
EM DIAGNOSTIC ECG ELECTRODE
K862746 · Electromed Intl., Ltd. · Aug 1986
EUROMED S-601
K862765 · Lectec Corp. · Aug 1986
EM STRESS ELECTRODE
K860827 · Electromed Intl., Ltd. · May 1986