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FDA 510(k)

MRidium 3870 MRI Infusion Pump System (3870)

K-Number: K242752 · 2025-05-28

ApplicantIradimed Corporation
Decision Date2025-05-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MRidium 3870 MRI Infusion Pump System (3870) is a medical device manufactured by Iradimed Corporation. It received FDA 510(k) clearance on 2025-05-28 under approval number K242752. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRidium 3870 MRI Infusion Pump System (3870)?

MRidium 3870 MRI Infusion Pump System (3870) is a medical device that received FDA 510(k) clearance on 2025-05-28. It is manufactured by Iradimed Corporation. The 510(k) number is K242752.

When was MRidium 3870 MRI Infusion Pump System (3870) approved by the FDA?

MRidium 3870 MRI Infusion Pump System (3870) received FDA 510(k) clearance on 2025-05-28, under approval number K242752.

What company makes MRidium 3870 MRI Infusion Pump System (3870)?

MRidium 3870 MRI Infusion Pump System (3870) is manufactured by Iradimed Corporation.

What is the FDA product code for MRidium 3870 MRI Infusion Pump System (3870)?

The FDA product code for MRidium 3870 MRI Infusion Pump System (3870) is FRN.

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Other Devices by Iradimed Corporation

K143369MRidium 3860+ MRI infusion Pump/ Monitoring System K1722003880 MRI Patient Monitoring System K1829003880 MRI Patient Monitoring System K1809033880 MRI Patient Monitoring System

Related Devices (Code: FRN)

K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. K161667Sapphire Infusion PumpQ Core Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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