Cleared Traditional

K090087 - MRIDIUM 3860 MRI INFUSION PUMP/MONITORI...

K090087 is an FDA 510(k) clearance for MRIDIUM 3860 MRI INFUSION PUMP/MONITORI..., manufactured by Iradimed Corporation. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K090087 · Iradimed Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
84d
Days
Class 2
Risk

K090087 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 Park, US). The FDA issued a Cleared decision on April 7, 2009 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iradimed Corporation devices

FDA 510(k) Submission Details - K090087

510(k) Number K090087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2009
Decision Date April 07, 2009
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FRN Device Classification - Class 2, Special Controls

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 460
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