Cleared Traditional

K974546 - BIOSENSOR HOLTER MONITOR SYSTEM

K974546 is an FDA 510(k) clearance for BIOSENSOR HOLTER MONITOR SYSTEM, manufactured by Biosensor Corp.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974546 · Biosensor Corp. · Cardiovascular device
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Mar 1998
Decision
90d
Days
Class 2
Risk

K974546 is an FDA 510(k) clearance for the BIOSENSOR HOLTER MONITOR SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosensor Corp. (Maple Grove, US). The FDA issued a Cleared decision on March 4, 1998 after a review of 90 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 Biosensor Corp. devices

FDA 510(k) Submission Details - K974546

510(k) Number K974546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1997
Decision Date March 04, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 304
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K974546.
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
K983102 · Cambridge Heart, Inc. · Apr 1999
MT-200
K973751 · Schiller America, Inc. · Aug 1998
BIOSENSOR HOLTER MONITOR SYSTEM
K974192 · Biosensor Corp. · Mar 1998
NIVP3 (WINDOWS VERSION OF NIVP
K970570 · D. E. Hokanson, Inc. · Oct 1997
SPACELABS MEDICAL ECG ANALYSIS SYSTEM
K962930 · Spacelabs Medical, Inc. · Apr 1997
STRESSWRITER EXERCISE TESTING SYSTEM
K961009 · Hewlett-Packard Co. · Jun 1996