# K211564: Sterile High-pressure Angiographic Syringes for Single-use

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Boon Medical Supply Co., Ltd.
- Decided: Oct 19, 2021 after 152 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: 8 generations back to K934086 (1995). 21 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192657: Sterile High-pressure Angiographic Syringes for Single-use, Shenzhen Boon Medical Supply Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K253048: High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube (2026), 0 descendants of its own
- K241109: Single-use Sterile High-pressure Angiographic Syringes and Accessories (2024), 0 descendants of its own

## Indications for use
Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with US legally marketed angiographic injectors.

Source page: https://510kreport.com/device/K211564
Methodology: https://510kreport.com/methodology