# K242752: MRidium 3870 MRI Infusion Pump System (3870)

- Pathway: 510(k) (Traditional)
- Applicant: Iradimed Corporation
- Decided: May 28, 2025 after 258 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002211 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143369: MRidium 3860+ MRI infusion Pump/ Monitoring System, Iradimed Corporation (2016) Summary page 5.

## Indications for use
The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet’s bore, up to a 15,000 Gauss magnetic field line. The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode. The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours. The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regard to neonatal subpopulations (i.e., low and extremely low birth weight). 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.

Source page: https://510kreport.com/device/K242752
Methodology: https://510kreport.com/methodology