# K210914: Sterile Syringe for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Suyun Medical Material Co., Ltd.
- Decided: Dec 17, 2021 after 263 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980987 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113241: BD Emerald Single Use, Hypodermic Syringe, Becton Dickinson (2011) Summary page 5.

## Indications for use
The Sterile Syringe for Single Use is intended for use by health care professionals for general purpose aspiration and injection of fluids.

Source page: https://510kreport.com/device/K210914
Methodology: https://510kreport.com/methodology