Cleared Traditional

K050301 - MRIDIUM 3850 MRI PUMP SYSTEM

K050301 is an FDA 510(k) clearance for MRIDIUM 3850 MRI PUMP SYSTEM, 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 44-day FDA review.

K050301 · Iradimed Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
44d
Days
Class 2
Risk

K050301 is an FDA 510(k) clearance for the MRIDIUM 3850 MRI PUMP 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 March 24, 2005 after a review of 44 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 - K050301

510(k) Number K050301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2005
Decision Date March 24, 2005
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
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 Consultant

Citech
ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRN Pump, Infusion

All 623
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K050301.
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
K043204 · Sgarlato Laboratories, Inc. · Mar 2005
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
K043600 · Medtronic Minimed · Mar 2005
SE INFUSION SYSTEM WITH MMS
K043590 · Cardinal Health, Alaris Products · Mar 2005
BODYGUARD INFUSION PUMP SYSTEM
K042696 · Caesarea Medical Electronics , Ltd. · Mar 2005
HARVARD 2 SYRINGE PUMP, MODEL 2001-001
K050107 · Harvard Clinical Technology · Feb 2005
PHARMGUARD TOOLBOX, MODEL G6000782
K042432 · Medex, Inc. · Jan 2005

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.