Cleared Traditional

K901948 - CARDISUNY 501BIII

K901948 is the FDA 510(k) clearance for CARDISUNY 501BIII by Graham-Field, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K901948 · Graham-Field, Inc. · Cardiovascular device
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Jul 1990
Decision
78d
Days
Class 2
Risk

K901948 is an FDA 510(k) clearance for the CARDISUNY 501BIII. 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

Submission Details

510(k) Number K901948 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.

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 162
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K901948.
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TRAMSCOPE SYSTEM
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NKA MODELS AB-601G AND AB-621G
K900272 · Nihon Kohden America, Inc. · Jan 1990
7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989