# K161261: Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

- Pathway: 510(k) (Traditional)
- Applicant: Genea Biomedx Pty, Ltd.
- Decided: May 12, 2017 after 373 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K034063 (2004). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153290: Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium, William A. Cook Australia Pty., Ltd. (2016) Summary page 4.
- K133568: G-TL, Vitrolife, Inc. (2014) Summary page 4.
- K143724: COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit, William A. Cook Australia Pty., Ltd. (2015) Summary page 4.

## Indications for use
Gems Fertilisation Medium is used to provide a suitable environment for both oocytes and sperm and support in vitro fertilisation. This medium can be used for transfer of zygotes into the uterus. Gems Cleavage Medium is for in vitro culture of embryos following fertilization to the 4-8 cell stage. This medium can be used for transfer of cleavage stage embryos into the uterus. Gems Blastocyst Medium is for in vitro culture of embryos from the cleavage stage to the blastocyst stage of development. This medium can be used for transfer of blastocyst stage embryos into the uterus. Gems Geri Medium is for in vitro culture of embryos from fertilization to the blastocyst stage of development. This medium can be used for transfer of embryos into the uterus. Gems VitBase is used to maintain embryos for a short period of time in a non-gassed environment during embryo vitrification and warming procedures. The embryos can be placed in this medium for a maximum of 10 minutes.

Source page: https://510kreport.com/device/K161261
Methodology: https://510kreport.com/methodology