# Shenzhen Vitavitro Biotech Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 5 (2019–2024): 5 510(k) clearances
- Product codes: MQL (3), MQE (1), MQF (1)
- 510(k) review time since 2016: median 182 days, against 257 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 3 (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
- Cook Ob/Gyn: 1 (https://510kreport.com/company/cook-ob-gyn)
- Life Global Group, LLC: 1 (https://510kreport.com/company/life-global-group)
- Advanced Reproductive Technologies: 1 (https://510kreport.com/company/advanced-reproductive-technologies)
- William A. Cook Australia Pty., Ltd.: 1 (https://510kreport.com/company/william-a-cook-australia)
- Gynetics Medical Products NV: 1 (https://510kreport.com/company/gynetics-medical-products)
- Vitrolife AB: 1 (https://510kreport.com/company/vitrolife)
- Kitazato Corporation: 1 (https://510kreport.com/company/kitazato)

## Firms that cite its devices most
- Vitromed GmbH: 1 (https://510kreport.com/company/vitromed)
- Artsmedia Denmark Aps: 1 (https://510kreport.com/company/artsmedia-denmark)
- Donnevie Medical Technology (Shanghai) Co., Ltd.: 1 (https://510kreport.com/company/donnevie-medical-technology-shanghai)

## Its most-cited devices
- K200408: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium (2020), cited by 1
- K191063: 1-Step Culture Medium (2019), cited by 1
- K212410: VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium (2022), cited by 1

## Recent decisions
- K240523: VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (Nov 15, 2024)
- K240307: VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (Aug 16, 2024)
- K212410: VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium (Feb 1, 2022)
- K200408: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium (Oct 16, 2020)
- K191063: 1-Step Culture Medium (Aug 23, 2019)

Source page: https://510kreport.com/company/shenzhen-vitavitro-biotech