# K050301: Mridium 3850 Mri Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Iradimed Corporation
- Decided: Mar 24, 2005 after 44 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002211 (2000). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- 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.

## Most influential descendants
- K090087: Mridium 3860 Mri Infusion Pump/Monitoring System (2009), 2 descendants of its own
- 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
- K073051: Medrad Continuum MR Infusion System with Wireless Remote Accessory (2008), 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
- Aug 24, 2012 · Class II · Z-0446-2013: Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications.

## Indications for use
The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with 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 specific MRidium 3850 Series Infusion Pump System (including the MRidium 1000 Series of Infusion Sets) indications for use are as follows: 1. Useful in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. 2. Useful in the following delivery routes: arterial, intravenous, spinal, subcutaneous, and enteral. 3. Useful in the following delivery modes: continuous, intermittent and bolus. 4. Although specifically intended for use in the MRI, this product can be useful in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the volumetric infusion pump can be monitored or supervised by a clinician. 5. Used inside the MRI room mounted outside the 10,000 Gauss line and with shielded magnets of field strength of 3.0 Tesla or less. The MRidium 1000 Series Infusion Sets are intended as accessories to the MRidium 3850 MRI Infusion Pump, and are used in the administration of fluids for precisely controlled infusion rates. The infusion pump is contra-indicated 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/K050301
Methodology: https://510kreport.com/methodology