Cleared Abbreviated

K051730 - MATRIX HOLTER SYSTEM, MODEL M12

K051730 is an FDA 510(k) clearance for MATRIX HOLTER SYSTEM, manufactured by Global Instrumentation, LLC. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Abbreviated 510(k) pathway after a 91-day FDA review.

K051730 · Global Instrumentation, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
91d
Days
Class 2
Risk

K051730 is an FDA 510(k) clearance for the MATRIX HOLTER SYSTEM, MODEL M12. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Global Instrumentation, LLC (Manlius, US). The FDA issued a Cleared decision on September 26, 2005 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K051730

510(k) Number K051730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date September 26, 2005
Days to Decision 91 days
Submission Type Abbreviated
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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Standards-based clearance path.

MLO Device Classification - Class 2, Special Controls

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 32
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K051730.
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
K092853 · Galix Biomedical Instrumentation, Inc. · Jul 2010
MEDICK MHM200 PERSONAL HEART MONITOR
K063339 · Medick Healthcare , Ltd. · Jun 2007
PREMIER 11 HOLTER
K062088 · Diagnostic Monitoring Software · Aug 2006
SEER MC
K042782 · Ge Medical Systems Information Technologies · Sep 2005
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
K043454 · Medicomp, Inc. · Mar 2005
VISTA PLUS
K042108 · Novacor · Jan 2005
K051730 · MATRIX HOLTER SYSTEM, MODEL M12
Download PDF FDA Summary Global Instrumentatio…