# K170279: Disposable High Pressure Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Union Medical Shenzhen Co., Ltd.
- Decided: Dec 12, 2017 after 316 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)
- K151960: Sterile High-pressure Angiographic Syringes for Single-use, Shenzhen Baoan Medical Supplies Co., Ltd. (2016) Summary page 7.

## Indications for use
The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors.

Source page: https://510kreport.com/device/K170279
Methodology: https://510kreport.com/methodology