Cleared Traditional

K897121 - QEKG ELECTROCARDIOGRAPH

K897121 is an FDA 510(k) clearance for QEKG ELECTROCARDIOGRAPH, manufactured by Qmed, Inc.. The device is a Class 2 Cardiovascular device with 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.

FDA 510(k) Submission Details - K897121

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
Combination Product No
PCCP Authorized No
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.

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 579
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K897121.
CARDISUNY 501AB
K901947 · Graham-Field, Inc. · Jul 1990
CARDISUNY 501BIII
K901948 · Graham-Field, Inc. · Jul 1990
SIEMENS SIRECUST 732, PATIENT MONITOR
K901771 · Siemens Medical Electronics · May 1990
MODEL ECG100 SIMULATOR
K897029 · Dynatech/Nevada, Inc. · Apr 1990
TRAMSCOPE SYSTEM
K900598 · Marquette Electronics, Inc. · Apr 1990
PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
K901032 · Accucore, Inc. · Apr 1990
K897121 · QEKG ELECTROCARDIOGRAPH
Download PDF Qmed, Inc.