# K152906: Disposable High Pressure Injector Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Yushou Medical Appliances Co., Ltd.
- Decided: Nov 22, 2016 after 418 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: 7 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)
- 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 4.
- 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, Shandong Weigao Medical Polymer Co., Ltd. (2009) Summary page 4.

## Indications for use
Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.

Source page: https://510kreport.com/device/K152906
Methodology: https://510kreport.com/methodology