Cleared Traditional

K897121 - QEKG ELECTROCARDIOGRAPH

K897121 is the FDA 510(k) clearance for QEKG ELECTROCARDIOGRAPH by Qmed, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K897121 · Qmed, Inc. · Cardiovascular device
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Apr 1990
Decision
125d
Days
Class 2
Risk

K897121 is an FDA 510(k) clearance for the QEKG ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Qmed, Inc. (Clark, US). The FDA issued a Cleared decision on April 30, 1990 after a review of 125 days - within the typical 510(k) review window.

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 Qmed, Inc. devices

Submission Details

510(k) Number K897121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date April 30, 1990
Days to Decision 125 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 125d · This submission: 125d
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 258
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K897121.
HORIZON 2000 ST ANALYSIS OPTION
K903524 · Mennen Medical, 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
CARDIOCAP(TM) CMX-104 MONITOR
K896190 · Datex Division Instrumentarium Corp. · Mar 1990
NKA MODELS AB-601G AND AB-621G
K900272 · Nihon Kohden America, Inc. · Jan 1990