# K092667: Global Dmso Blastocyst Vitrification Kit and Warming Kit

- Pathway: 510(k) (Traditional)
- Applicant: Genx Intl., Inc.
- Decided: Jun 3, 2010 after 276 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Global DMSO Blastocyst Vitrification Kit: Intended for the vitrification (ultra-rapid freezing) and cryostorage of human blastocysts. Global DMSO Blastocyst Vitrification Warming Kit Intended for the recovery and rehydration of vitrified human blastocysts Intended for use with blastocysts that have been vitrified using the Global DM80 Blastocyst Vitrification Kit.

Source page: https://510kreport.com/device/K092667
Methodology: https://510kreport.com/methodology