Cleared Traditional

K042108 - VISTA PLUS

K042108 is an FDA 510(k) clearance for VISTA PLUS, manufactured by Novacor. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K042108 · Novacor · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
168d
Days
Class 2
Risk

K042108 is an FDA 510(k) clearance for the VISTA PLUS. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Novacor (Rueil Malmaison Cedex, FR). The FDA issued a Cleared decision on January 19, 2005 after a review of 168 days - an extended review cycle.

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. 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 Novacor devices

FDA 510(k) Submission Details - K042108

510(k) Number K042108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2004
Decision Date January 19, 2005
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
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 15
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K042108.
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
K110569 · Inovise Medical, Inc. · Oct 2011
SEER MC
K042782 · Ge Medical Systems Information Technologies · Sep 2005
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
K043454 · Medicomp, Inc. · Mar 2005
H-SCRIBE
K004017 · Mortara Instrument, Inc. · Jun 2001
GALIX GBI -3S-LP
K992706 · Galix Biomedical Instrumentation, Inc. · Mar 2001
R.TEST EVOLUTION
K993788 · Novacor Div. · Aug 2000