# K212846: Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Jichun Medical Devices Co., Ltd.
- Decided: Aug 30, 2022 after 357 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: 7 generations back to K931367 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use, Shanghai Kohope Medical Devices Co., Ltd. (2019) Summary page 5.

## Indications for use
Sterile Hypodermic Syringe for Single Use, with/without needle: The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration and injection of fluids for medical purposes. Sterile Hypodermic Needle for Single use: The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes.

Source page: https://510kreport.com/device/K212846
Methodology: https://510kreport.com/methodology