# K143369: MRidium 3860+ MRI infusion Pump/ Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Iradimed Corporation
- Decided: Dec 15, 2016 after 751 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002211 (2000). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090087: Mridium 3860 Mri Infusion Pump/Monitoring System, Iradimed Corporation (2009) Summary page 4.

## Most influential descendants
- K242752: MRidium 3870 MRI Infusion Pump System (3870) (2025), 0 descendants of its own

## Recalls of this device
- Feb 24, 2023 · Class II · Z-1310-2023: Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venti

## Indications for use
The Iradimed Corporation's MRidium 3860+ MRI Infusion Pump/Monitoring System is intended for: - General hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. - The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in either continuous, intermittent, or bolus delivery mode. - The Infusion Pump can be used inside the MRI room mounted outside the 10,000 Gauss line (1 Tesla line), and with shielded magnets of field strength of 3.0 Tesla or less. - This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications. - The Pulse Oximeter is used to measure, display, and record functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing of the oximeter was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot checking and/or continuous monitoring of patients who are well or poorly perfused in the MRI. The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100 mmHG as the high negative pressures can result in uncontrolled fluid flow.

Source page: https://510kreport.com/device/K143369
Methodology: https://510kreport.com/methodology