# Gemtier Medical (Shanghai), Inc.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 5 (2017–2022): 5 510(k) clearances
- Product codes: FXX (2), MEG (2), FMI (1)
- 510(k) review time since 2016: median 191 days, against 216 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xiantao Rayxin Medical Products Co., Ltd.: 1 (https://510kreport.com/company/xiantao-rayxin-medical-products)
- Demetech Corp.: 1 (https://510kreport.com/company/demetech)
- Yangzhou Medline Industry, Co., Ltd.: 1 (https://510kreport.com/company/yangzhou-medline-industry)
- Greiner Bio-One North America, Inc.: 1 (https://510kreport.com/company/greiner-bio-one-north-america)

## Firms that cite its devices most
- Promisemed Hangzhou Meditech Co., Ltd.: 1 (https://510kreport.com/company/promisemed-hangzhou-meditech)

## Its most-cited devices
- K192679: Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use (2020), cited by 1
- K170276: Safety Blood Collection Device for Single Use (2017), cited by 1

## Recent decisions
- K212652: Sterile Syringe with Fixed Safety Needle for Single Use (Mar 2, 2022)
- K202493: Medical Face Mask (Feb 4, 2021)
- K202331: Medical Face Mask (Feb 2, 2021)
- K192679: Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use (Apr 10, 2020)
- K170276: Safety Blood Collection Device for Single Use (Dec 11, 2017)

Source page: https://510kreport.com/company/gemtier-medical-shanghai