# K061128: Modification to Medrad Continuum MR Infusion System

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: May 22, 2006 after 28 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: 2 generations back to K021988 (2002). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 7 devices in its family (counting itself) has 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.

## 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

## Indications for use
The MEDRAD Continuum MR Compatible Infusion System (3T Proximity) is designed for patients who require maintenance medications and 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/K061128
Methodology: https://510kreport.com/methodology