# K053552: Global Fertilization, Embryo Culture and Transfer Media

- Pathway: 510(k) (Traditional)
- Applicant: <Genx> Intl., Inc.
- Decided: May 19, 2006 after 150 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices 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.

## Most influential descendants
- K072609: Single Step Medium (2008), 9 descendants of its own
- K121572: Continuous Single Culture Complete (2012), 8 descendants of its own
- K133568: G-TL (2014), 4 descendants of its own
- K191063: 1-Step Culture Medium (2019), 1 descendant of its own
- K170681: Continuous Single Culture -NX (CSCM-NX) (2017), 1 descendant of its own

## Indications for use
global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.

Source page: https://510kreport.com/device/K053552
Methodology: https://510kreport.com/methodology