# K081117: G-2 V5

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Sep 16, 2008 after 151 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: 1 generation back to K021890 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021890: G-2 Version 3, Model 10049, Vitrolife Sweden AB (2002) Summary page 1.

## Indications for use
G-2 v5 is indicated for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer G-2 v5 PLUS is indicated for culture of embryos from day 3 to the blastocyst stage, and for embryo transfer

Source page: https://510kreport.com/device/K081117
Methodology: https://510kreport.com/methodology