Cleared Traditional

MRidium 3860+ MRI infusion Pump/ Monitoring System (K143369) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143369 · Iradimed Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
751d
Days
Class 2
Risk

K143369 is an FDA 510(k) clearance for the MRidium 3860+ MRI infusion Pump/ Monitoring System. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Iradimed Corporation (Winter Springs, US). The FDA issued a Cleared decision on December 15, 2016 after a review of 751 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Iradimed Corporation devices

Submission Details

510(k) Number K143369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2014
Decision Date December 15, 2016
Days to Decision 751 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
622d slower than avg
Panel avg: 129d · This submission: 751d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 236
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K143369.
Power Infuser
K172653 · ZOLL Medical Corporation · Jul 2018
Perfusor® Space Syringe Infusion Pump System
K172831 · B.Braun Medical, Inc. · Jun 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · Baxter Healthcare Corporation · May 2018
Infusomat Space Volumetric Infusion Pump
K142596 · B.Braun Medical, Inc. · Jun 2015
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K083689 · B.Braun Medical, Inc. · Jul 2009
COLLEAGUE GUARDIAN CONFIGURATION TOOL
K070125 · Baxter Healthcare Corp · Apr 2007