# K022245: G-Fert, Model 10033

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Sep 6, 2002 after 56 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081116: G-Ivf G5 Series (2008), 2 descendants of its own
- K202862: Gx-IVF, Gx-TL, Gx-MOPS PLUS (2021), 0 descendants of its own
- K153478: Sydney IVF Gamete Buffer (2016), 0 descendants of its own

## Indications for use
Medium for preparation and handling of gametes and for in vitro fertilization.

Source page: https://510kreport.com/device/K022245
Methodology: https://510kreport.com/methodology