Cleared Traditional

K042782 - SEER MC

K042782 is an FDA 510(k) clearance for SEER MC, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K042782 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
331d
Days
Class 2
Risk

K042782 is an FDA 510(k) clearance for the SEER MC. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on September 2, 2005 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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. Elevated predicate reliance profile. 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 Systems Information Technologies devices

FDA 510(k) Submission Details - K042782

510(k) Number K042782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2004
Decision Date September 02, 2005
Days to Decision 331 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
206d slower than avg
Panel avg: 125d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 30
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K042782.
MEDICK MHM200 PERSONAL HEART MONITOR
K063339 · Medick Healthcare , Ltd. · Jun 2007
PREMIER 11 HOLTER
K062088 · Diagnostic Monitoring Software · Aug 2006
MATRIX HOLTER SYSTEM, MODEL M12
K051730 · Global Instrumentation, LLC · Sep 2005
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
K043454 · Medicomp, Inc. · Mar 2005
VISTA PLUS
K042108 · Novacor · Jan 2005
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
K024323 · Biomedical Systems Corp. · Jun 2003