# K212857: Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Zhiyu Medical Instrument Co, Ltd.
- Decided: May 9, 2023 after 608 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: 8 generations back to K931367 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201284: Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use, Set Medikal Sanayi VE Ticaret Anonim Sirketi (2020) Summary page 5.

## Indications for use
The Sterile Syringe for Single Use (with Needle) is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The Sterile Hypodermic Needle for Single Use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Source page: https://510kreport.com/device/K212857
Methodology: https://510kreport.com/methodology