# K162409: Gems Vitrification Set, Gems Warming Set

- Pathway: 510(k) (Traditional)
- Applicant: Genea Biomedx Pty, Ltd.
- Decided: May 24, 2017 after 268 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: 3 generations back to K060168 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 Vitrification Set is used for the vitrification of human blastocyst stage embryos for Assisted Reproductive Technology (ART) procedures. Gems Warming Set is used for the warming of human blastocyst stage embryos that have undergone vitrification.

Source page: https://510kreport.com/device/K162409
Methodology: https://510kreport.com/methodology