Cleared Traditional

K040915 - MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M

K040915 is an FDA 510(k) clearance for MAGNITUDE 3150M MRI PATIENT MONITOR, manufactured by Invivo Research, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K040915 · Invivo Research, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2004
Decision
167d
Days
Class 2
Risk

K040915 is an FDA 510(k) clearance for the MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Invivo Research, Inc. (Orlando, US). The FDA issued a Cleared decision on September 22, 2004 after a review of 167 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Invivo Research, Inc. devices

FDA 510(k) Submission Details - K040915

510(k) Number K040915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date September 22, 2004
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 180
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