# K180188: Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

- Pathway: 510(k) (Traditional)
- Applicant: Genea Biomedx Pty, Ltd.
- Decided: Jun 7, 2018 after 135 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. Geri Connect and Geri Assess are optional software accessories for the Geri Embryo Incubator. Geri Connect is intended for access and review of time-lapse data generated by the Geri Embryo Incubator on a local area network. Geri Assess is intended for viewing and recording embryo development events from images captured using the Geri Embryo Incubator. Geri Assess includes a user annotation function for capturing information on embryo development parameters and a user-defined modelling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection. Geri Connect and Geri Assess do not control any hardware components in the Geri Embryo Incubator. Geri Connect and Geri Assess are combined in the same software package and must be used together. 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/K180188
Methodology: https://510kreport.com/methodology