Cleared Traditional

K172200 - 3880 MRI Patient Monitoring System

K172200 is an FDA 510(k) clearance for 3880 MRI Patient Monitoring System, manufactured by Iradimed Corporation. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K172200 · Iradimed Corporation · Cardiovascular device
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Oct 2017
Decision
96d
Days
Class 2
Risk

K172200 is an FDA 510(k) clearance for the 3880 MRI Patient Monitoring System. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Iradimed Corporation (Winter Springs, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 96 days - within the typical 510(k) review window.

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 Iradimed Corporation devices

FDA 510(k) Submission Details - K172200

510(k) Number K172200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2017
Decision Date October 25, 2017
Days to Decision 96 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
29d faster than avg
Panel avg: 125d · This submission: 96d
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 151
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K172200.
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