# Donnevie Medical Technology (Shanghai) Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 4 (2022–2025): 4 510(k) clearances
- Product codes: MQL (4)
- 510(k) review time since 2016: median 158 days, against 225 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 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
- William A. Cook Australia Pty., Ltd.: 2 (https://510kreport.com/company/william-a-cook-australia)
- Shenzhen Vitavitro Biotech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-vitavitro-biotech)
- Kitazato Corporation: 1 (https://510kreport.com/company/kitazato)

## Recent decisions
- K251637: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (Aug 27, 2025)
- K242561: Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (Apr 10, 2025)
- K231370: Dewin Blastocyst Medium (with HSA and without HSA) (Aug 4, 2023)
- K212426: Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) (Jun 16, 2022)

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