# K031483: Medrad Manual Syringe Loader

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Aug 1, 2003 after 81 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934086 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012950: Modification to: Medrad Spectris Solaris MR Injector System, Medrad, Inc. (2001)
- K023183: Medrad Stellant CT Injector System, Medrad, Inc. (2003)

## Indications for use
The Medrad Manual Syringe Loader is designed as an accessory to Medrad's line of angiographic injectors and syringes. It is intended to facilitate manual syringe contrast filling. It is not intended for patient use or use as a contrast injector.

Source page: https://510kreport.com/device/K031483
Methodology: https://510kreport.com/methodology