# K030323: Mri-Caddy

- Pathway: 510(k) (Traditional)
- Applicant: Mammendorfer Institute For Physics & Medicine GmbH
- Decided: Apr 2, 2003 after 62 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Syringe Infusion Pump, Model 3001: named in the summary without a submission number
- (no number) Medfusion Model 2001 Syringe Infusion Pump: named in the summary without a submission number

## Most influential descendants
- K191910: SpaceStation MRI (2020), 0 descendants of its own

## Indications for use
The intended medical application of MRI-Caddy with three 2000-Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times. The MRI-Caddy is designed for use in an MR-environment at a maximum magnetic field strength of 20mT.

Source page: https://510kreport.com/device/K030323
Methodology: https://510kreport.com/methodology