Cleared Traditional

K042148 - HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES

K042148 is an FDA 510(k) clearance for HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES, manufactured by Ge Medical Syst. Information Technologies. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K042148 · Ge Medical Syst. Information Technologies · Cardiovascular device
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Dec 2004
Decision
116d
Days
Class 2
Risk

K042148 is an FDA 510(k) clearance for the HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Ge Medical Syst. Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on December 3, 2004 after a review of 116 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 Ge Medical Syst. Information Technologies devices

FDA 510(k) Submission Details - K042148

510(k) Number K042148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2004
Decision Date December 03, 2004
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
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 307
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K042148.
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K042002 · Ela Medical, Inc. · Oct 2004
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
K032513 · Ge Medical Systems Information Technologies · Oct 2003
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K032577 · Ge Medical Systems Information Technologies · Oct 2003