# K140469: MR Syringe Dual Pack

- Pathway: 510(k) (Traditional)
- Applicant: Coeur, Inc.
- Decided: Jul 28, 2014 after 153 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: 6 generations back to K934086 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984088: Optistar MR Injector System, Mallinckrodt Inc., Liebel-Flarsheim Business (1999) Summary page 1.
- K051799: Disposable CT/MR Syringes for Nemoto Injectors, Coeur, Inc. (2005) Summary page 1.
- K852580: Monoject Sterile 60CC Syringes, Sherwood Medical Co. (1985) Summary page 1.
- K072696: Ant Angiographic Syringes, Model (S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301, Shenzhen Ant Hi-Tech Industrial Co., Ltd. (2008) Summary page 1.

## Indications for use
For use with the LE OptiStar Injector for injection of contrast media or saline.

Source page: https://510kreport.com/device/K140469
Methodology: https://510kreport.com/methodology