Cleared Traditional

K840875 - MULTIVARIATE DIGITAL CARDIOGRAPH

K840875 is an FDA 510(k) clearance for MULTIVARIATE DIGITAL CARDIOGRAPH, manufactured by Clinical Microsystems Intl.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K840875 · Clinical Microsystems Intl. · Cardiovascular device
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Jul 1984
Decision
130d
Days
Class 2
Risk

K840875 is an FDA 510(k) clearance for the MULTIVARIATE DIGITAL CARDIOGRAPH. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Clinical Microsystems Intl. (Walker, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Clinical Microsystems Intl. devices

FDA 510(k) Submission Details - K840875

510(k) Number K840875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date July 06, 1984
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 389
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K840875.
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985
SPACELABS-GENERAL SYSTEM LINK
K850627 · Spacelabs, Inc. · May 1985
COMPUSTRESS STRESS TESTING SYS
K842339 · Intl. Medical, Inc. · Dec 1984
Q3000
K834567 · Quinton, Inc. · Apr 1984
KONTRON PMS 7000
K812354 · Kontron Instruments, Inc. · Sep 1981
MODEL IM1000 INTEGRATED MONITOR
K810731 · Gould, Inc. · Mar 1981