← Back to catalogue

MRidium 3870 MRI Infusion Pump System (3870)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242752

by Iradimed Corporation

Identifiers

510(k) Number
K242752 FDA 510(k)
FDA Product Code
FRN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MRidium 3870 MRI Infusion Pump System (3870) is a pump, infusion device designed for general hospital or clinical use. It is intended for infusing patients with intravenous fluids in environments where a large magnetic field may be present, such as Magnetic Resonance Imaging (MRI).

The device is supplied as a system and can be used during transport. It is authorized under FDA 510(k) clearance (K242752) and is classified as a Class II medical device. The system is designed to operate safely in ultra-high magnetic fields without requiring workarounds typical of general hospital infusion pumps.

Frequently asked questions

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

The MRidium 3870 MRI Infusion Pump System (3870) is intended for infusing patients with intravenous fluids in hospital or clinical settings where a large magnetic field may be present, such as during Magnetic Resonance Imaging (MRI) procedures, ensuring safe operation without requiring workarounds typical of standard infusion pumps.

How is the MRidium 3870 MRI Infusion Pump System (3870) supplied and can it be used during transport?

The device is supplied as a complete system and is designed for use during patient transport, allowing continuous intravenous fluid infusion while moving patients to and from MRI suites or within the facility, maintaining functionality in high magnetic field environments.

What regulatory authorization does the MRidium 3870 MRI Infusion Pump System (3870) have?

The MRidium 3870 MRI Infusion Pump System (3870) is authorized under FDA 510(k) clearance with the number K242752, and is classified as a Class II medical device, indicating it has demonstrated substantial equivalence to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 3870 MRI Infusion Pump — IRadimed, New 3870 MRI IV Pump System — IRadimed, MRidium 3870 MRI Infusion Pump System (3870) (K242752) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Iradimed Corporation

Sources (1)

  • FDA 510(k) K242752 24 fields · synced Sep 25, 2026