Cleared Special

K014108 - MAC 5000 ECG ANALYSIS SYSTEM

K014108 is an FDA 510(k) clearance for MAC 5000 ECG ANALYSIS SYSTEM, manufactured by General Electric Medical Systems Information Techn. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 28-day FDA review.

K014108 · General Electric Medical Systems Information Techn · Cardiovascular device
Download Printable Device Report (PDF)
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Jan 2002
Decision
28d
Days
Class 2
Risk

K014108 is an FDA 510(k) clearance for the MAC 5000 ECG ANALYSIS SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on January 10, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all General Electric Medical Systems Information Techn devices

FDA 510(k) Submission Details - K014108

510(k) Number K014108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2001
Decision Date January 10, 2002
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 374
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K014108.
QUINTON Q-CATH, MODEL 000460
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ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM
K012206 · Cambridge Heart, Inc. · Oct 2001
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K011324 · Cambridge Heart, Inc. · May 2001