# K180304: Geri Embryo Incubator and Geri Dish

- Pathway: 510(k) (Special)
- Applicant: Genea Biomedx Pty, Ltd.
- Decided: Apr 20, 2018 after 77 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K040717 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171736: Geri Embryo Incubator and Geri Dish, Genea Biomedx Pty, Ltd. (2017) Summary page 4.

## Indications for use
The Geri Embryo Incubator is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Geri Embryo Incubator has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours. The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.

Source page: https://510kreport.com/device/K180304
Methodology: https://510kreport.com/methodology