# K212652: Sterile Syringe with Fixed Safety Needle for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Gemtier Medical (Shanghai), Inc.
- Decided: Mar 2, 2022 after 191 days
- Product code: MEG (Syringe, Antistick)
- 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 K771205 (1977). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192679: Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Gemtier Medical (Shanghai), Inc. (2020) Summary page 5.

## Indications for use
Sterile Syringe with Fixed Safety 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 mechanism can be manually activated to cover the needle immediately to minimize risk of accidental needlesticks.

Source page: https://510kreport.com/device/K212652
Methodology: https://510kreport.com/methodology