# K212920: Sterile Safety Syringe with Needle for Single Use,  Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Weigao Group Medical Polymer Co., Ltd.
- Decided: Mar 11, 2022 after 178 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 K771205 (1977). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle, Yangzhou Medline Industry, Co., Ltd. (2017) Summary page 5.
- K201234: BD SoloShot Mini Syringe/ BD Auto Disable Syringe, Becton, Dickinson and Company (2020) Summary page 5.

## Most influential descendants
- K260514: Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle (2026), 0 descendants of its own

## Indications for use
The Sterile Safety Syringe with Needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The Sterile Safety Hypodermic Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.

Source page: https://510kreport.com/device/K212920
Methodology: https://510kreport.com/methodology