Cleared Traditional

K180903 - 3880 MRI Patient Monitoring System

K180903 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 357-day FDA review.

K180903 · Iradimed Corporation · Cardiovascular device
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Mar 2019
Decision
357d
Days
Class 2
Risk

K180903 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 March 29, 2019 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Iradimed Corporation devices

FDA 510(k) Submission Details - K180903

510(k) Number K180903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2018
Decision Date March 29, 2019
Days to Decision 357 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
232d slower than avg
Panel avg: 125d · This submission: 357d
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 150
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K180903.
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