Cleared Traditional

K901947 - CARDISUNY 501AB

K901947 is an FDA 510(k) clearance for CARDISUNY 501AB, manufactured by Graham-Field, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K901947 · Graham-Field, Inc. · Cardiovascular device
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Jul 1990
Decision
78d
Days
Class 2
Risk

K901947 is an FDA 510(k) clearance for the CARDISUNY 501AB. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Graham-Field, Inc. (Hauppauge, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Graham-Field, Inc. devices

FDA 510(k) Submission Details - K901947

510(k) Number K901947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date July 17, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 333
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K901947.
MODEL 405
K904606 · Ivy Biomedical Systems, Inc. · Mar 1991
CARDIOFAX ECG-8830A
K904758 · Nihon Kohden America, Inc. · Dec 1990
FUKUDA DENSHI MODEL FX-3101
K901817 · Fukuda Denshi USA, Inc. · Aug 1990
TRAMSCOPE SYSTEM
K900598 · Marquette Electronics, Inc. · Apr 1990
SMU 611 UNIVERSALMONITOR
K900700 · Ppg Industries, Inc. · Apr 1990
CARDIOCAP(TM) CMX-104 MONITOR
K896190 · Datex Division Instrumentarium Corp. · Mar 1990