# Genea Biomedx Pty, Ltd.

- Location (FDA's records): Sydney, AU
- FDA decisions: 6 (2017–2018): 6 510(k) clearances
- Product codes: MQL (3), MQG (3)
- 510(k) review time since 2016: median 223 days, against 113 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 2 (2 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.: 3 (https://510kreport.com/company/william-a-cook-australia)
- Unisense Fertilitech A/S: 2 (https://510kreport.com/company/unisense-fertilitech-a-s)
- Vitrolife AB: 1 (https://510kreport.com/company/vitrolife)
- Cook Ob/Gyn: 1 (https://510kreport.com/company/cook-ob-gyn)

## Its most-cited devices
- K171736: Geri Embryo Incubator and Geri Dish (2017), cited by 2

## Recent decisions
- K180188: Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (Jun 7, 2018)
- K180304: Geri Embryo Incubator and Geri Dish (Apr 20, 2018)
- K171736: Geri Embryo Incubator and Geri Dish (Nov 15, 2017)
- K170498: Gems Oocyte Retrieval Buffer ORB-20, ORB-50 (Sep 28, 2017)
- K162409: Gems Vitrification Set, Gems Warming Set (May 24, 2017)
- K161261: Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase (May 12, 2017)

Source page: https://510kreport.com/company/genea-biomedx