Cleared Traditional

K900246 - CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512

K900246 is an FDA 510(k) clearance for CARDIOTEST EK 53 R, manufactured by Ppg Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K900246 · Ppg Industries, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
167d
Days
Class 2
Risk

K900246 is an FDA 510(k) clearance for the CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (Pleasantville, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 167 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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.

FDA 510(k) Submission Details - K900246

510(k) Number K900246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date July 03, 1990
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 339
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K900246.
MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
K900607 · Cardiodata Corp. · Oct 1990
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
K903704 · Fukuda Denshi USA, Inc. · Sep 1990
TRAM PATIENT MONITOR
K900540 · Marquette Electronics, Inc. · Jul 1990
SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
K900319 · Siemens Medical Electronics · Jun 1990
PCI MODEL 2041-B TELEMETRY MONITOR
K896775 · Accucore, Inc. · May 1990
MODEL 215M PATIENT SIMULATOR
K897074 · Dynatech/Nevada, Inc. · May 1990
K900246 · CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
Download PDF Ppg Industries, Inc.