# K090087: Mridium 3860 Mri Infusion Pump/Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Iradimed Corporation
- Decided: Apr 7, 2009 after 84 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002211 (2000). 8 ancestors in all.
2 later devices descend 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)
- K050301: Mridium 3850 Mri Pump System, Iradimed Corporation (2005) Summary page 1.
- K032771: Medrad Continuum MR Infusion System, Medrad, Inc. (2003) Summary page 1.
- K021988: Medrad Continuum MR Compatible Infusion System, Medrad, Inc. (2002) Summary page 1.
- K061128: Modification to Medrad Continuum MR Infusion System, Medrad, Inc. (2006) Summary page 1.
- K012383: Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C, Alaris Medical Systems, Inc. (2001) Summary page 1.
- K060479: Modification to Bodyguard Infusion Pump System, Caesarea Medical Electronics, Ltd. (2006) Summary page 1.
- (no number) Nonin 7500FO Pulse Oximeter: named in the summary without a submission number

## Most influential descendants
- K143369: MRidium 3860+ MRI infusion Pump/ Monitoring System (2016), 1 descendant of its own
- 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
- Jul 1, 2013 · Class I · Z-1874-2013: The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusio

## Indications for use
The MRidium 3860 Series MRI Infusion Pump/Monitoring System indications for use are as follows: 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. 4. This device is available for sale only upon the order of a physician or other related licensed medical professional, and is 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/K090087
Methodology: https://510kreport.com/methodology