# K051799: Disposable CT/MR Syringes for Nemoto Injectors

- Pathway: 510(k) (Traditional)
- Applicant: Coeur, Inc.
- Decided: Nov 2, 2005 after 120 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: 4 generations back to K934086 (1995). 17 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965214: Coeur Front Load Injector Retrofit Kit (C859-0002), Coeur Laboratories, Inc. (1997) Summary page 1.
- K960965: Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211, Coeur Laboratories, Inc. (1996) Summary page 1.
- K971712: Coeur 130 ML Angiographic Syringe, Coeur Laboratories, Inc. (1997) Summary page 1.
- K983826: 3S Injector-CT Contrast Delivery System, Unimachs Corp. (2000) Summary page 1.
- K033881: Medrad Stellant CT Injector System with Imaging System Interface Module, Medrad, Inc. (2004) Summary page 1.
- K880493: Medrad Microprocessor CT Injection System, Medrad, Inc. (1988) Summary page 1.
- K912944: CT 8000 Digital Injection System, Mallinckrodt Group, Inc. (1992) Summary page 1.
- K984088: Optistar MR Injector System, Mallinckrodt Inc., Liebel-Flarsheim Business (1999) Summary page 1.
- K864227: Percupump (TM), E-Z-Em, Inc. (1987) Summary page 1.
- K973334: OZ Power Syringe, Cardiovascular Innovations (1998) Summary page 1.

## Most influential descendants
- K072696: Ant Angiographic Syringes, Model (S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 (2008), 15 descendants of its own
- K151960: Sterile High-pressure Angiographic Syringes for Single-use (2016), 8 descendants of its own
- K192657: Sterile High-pressure Angiographic Syringes for Single-use (2020), 4 descendants of its own
- K211564: Sterile High-pressure Angiographic Syringes for Single-use (2021), 2 descendants of its own
- K082439: Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT (2009), 2 descendants of its own

## Indications for use
Syringe for injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors.

Source page: https://510kreport.com/device/K051799
Methodology: https://510kreport.com/methodology