Cleared Traditional

K890875 - CARDIOTEST EK53/EK53R

K890875 is the FDA 510(k) clearance for CARDIOTEST EK53/EK53R by Ppg Industries, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K890875 · Ppg Industries, Inc. · Cardiovascular device
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Oct 1989
Decision
238d
Days
Class 2
Risk

K890875 is an FDA 510(k) clearance for the CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (Pleasantville, US). The FDA issued a Cleared decision on October 17, 1989 after a review of 238 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Ppg Industries, Inc. devices

Submission Details

510(k) Number K890875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1989
Decision Date October 17, 1989
Days to Decision 238 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 170
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K890875.
CARDIOFAX ECG-8830A
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TRAMSCOPE SYSTEM
K900598 · Marquette Electronics, Inc. · Apr 1990
NKA MODELS AB-601G AND AB-621G
K900272 · Nihon Kohden America, Inc. · Jan 1990
7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
K883402 · Quinton, Inc. · Jan 1989
Q5000 ST/HR SLOPE MODIFICATION
K883468 · Quinton, Inc. · Dec 1988