# K021988: Medrad Continuum MR Compatible Infusion System

- Pathway: 510(k) (Abbreviated)
- Applicant: Medrad, Inc.
- Decided: Aug 29, 2002 after 72 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K032771: Medrad Continuum MR Infusion System (2003), 7 descendants of its own
- K061128: Modification to Medrad Continuum MR Infusion System (2006), 4 descendants of its own
- K050301: Mridium 3850 Mri Pump System (2005), 4 descendants of its own
- 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

## Recalls of this device
- Mar 22, 2005 · Not classified · Z-0841-05: Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.

## Indications for use
The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids intravenously, during an MR procedure. The Continuum is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure, functioning while stationary or mobile. It is not intended to provide long-term patient care outside of 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/K021988
Methodology: https://510kreport.com/methodology