# K212207: Sterile Hypodermic Syringe for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Weigao Group Medical Polymer Co., Ltd.
- Decided: Mar 23, 2023 after 616 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 6.

## Indications for use
The Sterile Hypodermic Syringe with needle, for Single Use is intended to be used for medical purposes to inject fluid into body.

Source page: https://510kreport.com/device/K212207
Methodology: https://510kreport.com/methodology