# K092963: Global Blastocyst Vitrification Kit & Vitrification Thawing Kit - Based on S3

- Pathway: 510(k) (Traditional)
- Applicant: Genx Intl., Inc.
- Decided: Jan 14, 2011 after 476 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jun 13, 2022 · Class II · Z-1421-2022: There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indica

## Indications for use
Media Intended for cryopreservation of human blastocysts. Media intended for the thawing and recovery of human blastocysts that have been cryopreserved using the VA-global® Blastocyst Fast Freeze Kit - Based on S3.

Source page: https://510kreport.com/device/K092963
Methodology: https://510kreport.com/methodology