Cleared Traditional

K864260 - APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)

K864260 is the FDA 510(k) clearance for APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) by Grandcor Medical Systems. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K864260 · Grandcor Medical Systems · Cardiovascular device
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May 1987
Decision
194d
Days
Class 2
Risk

K864260 is an FDA 510(k) clearance for the APPLICARD SYSTEM (ECG ELECTRODE SYSTEM). Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Grandcor Medical Systems (Dayton, US). The FDA issued a Cleared decision on May 11, 1987 after a review of 194 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 Grandcor Medical Systems devices

Submission Details

510(k) Number K864260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1986
Decision Date May 11, 1987
Days to Decision 194 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 125d · This submission: 194d
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 45
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K864260.
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
K874424 · Hewlett-Packard Co. · Jan 1988
MACTRODE-II
K872784 · Marquette Electronics, Inc. · Oct 1987
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868 · Hewlett-Packard Co. · Jan 1987
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246 · Conmedcorp · Aug 1986
CANMED 102
K844099 · Medtronic Vascular · Dec 1984