# K222124: Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Decided: Nov 4, 2022 after 109 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K000572 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060211: Wuzhou Syringe, with/Without Needle, Wenzhou Wuzhou Group Co., Ltd. (2006) Summary page 4.

## Indications for use
Sterile Hypodermic Syringe with/without needle The Sterile Hypodermic Syringe with/without needle is intended for use in the aspiration and injection of fluids for medical purposes. Sterile Hypodermic Needle The Sterile Hypodermic Needle is intended to be used with a syringe for fluids aspiration and injection for medical purposes.

Source page: https://510kreport.com/device/K222124
Methodology: https://510kreport.com/methodology