# K171736: Geri Embryo Incubator and Geri Dish

- Pathway: 510(k) (Traditional)
- Applicant: Genea Biomedx Pty, Ltd.
- Decided: Nov 15, 2017 after 156 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: 5 generations back to K040717 (2004). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113075: Embryo Viewer Software, Unisense Fertilitech A/S (2011) Summary page 4.
- K092183: Embryoscope and Embryoslide, Unisense Fertilitech A/S (2011) Summary page 4.

## Most influential descendants
- K180188: Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (2018), 0 descendants of its own
- K180304: Geri Embryo Incubator and Geri Dish (2018), 0 descendants of its own

## 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/K171736
Methodology: https://510kreport.com/methodology