Cleared Traditional

MARS HOLTER ANALYSIS WORKSTATION (K051026) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051026 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
88d
Days
Class 2
Risk

K051026 is an FDA 510(k) clearance for the MARS HOLTER ANALYSIS WORKSTATION. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K051026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2005
Decision Date July 19, 2005
Days to Decision 88 days
Submission Type Traditional
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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 183
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K051026.
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741 · Ge Healthcare · Sep 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
K052976 · Ge Healthcare · Jan 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
K052977 · Ge Healthcare · Nov 2005
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K050093 · Ge Medical Systems Information Technologies · May 2005
MUSE CARDIOLOGY INFORMATION SYSTEM
K050614 · Ge Medical Systems Information Technologies · Apr 2005
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
K032513 · Ge Medical Systems Information Technologies · Oct 2003