Cleared Traditional

CARDIOPHONE (K894856) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894856 · Euro-American Marketing Group, Inc. · Cardiovascular device
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Jan 1990
Decision
171d
Days
Class 2
Risk

K894856 is an FDA 510(k) clearance for the CARDIOPHONE. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Euro-American Marketing Group, Inc. (Mount Prospect, US). The FDA issued a Cleared decision on January 18, 1990 after a review of 171 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Euro-American Marketing Group, Inc. devices

Submission Details

510(k) Number K894856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date January 18, 1990
Days to Decision 171 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 125d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 53
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K894856.
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MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
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MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
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MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING
K893471 · Medtronic Vascular · Sep 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · Hewlett-Packard Co. · Sep 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · Medtronic Vascular · Jul 1989