# K073051: Medrad Continuum MR Infusion System with Wireless Remote Accessory

- Pathway: 510(k) (Abbreviated)
- Applicant: Medrad, Inc.
- Decided: May 30, 2008 after 214 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: 3 generations back to K002211 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061128: Modification to Medrad Continuum MR Infusion System, Medrad, Inc. (2006) Summary page 1.
- K050301: Mridium 3850 Mri Pump System, Iradimed Corporation (2005) Summary page 1.

## Recalls of this device
- Apr 3, 2014 · Class II · Z-1673-2014: There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.
- Apr 18, 2012 · Class II · Z-0595-2013: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159,

## Indications for use
The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Source page: https://510kreport.com/device/K073051
Methodology: https://510kreport.com/methodology