# K081114: G-1 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 K022244 (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)
- K022244: G-1 Version 3, Model 10048, Vitrolife Sweden AB (2002) Summary page 2.

## Indications for use
G-1TM v5 is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3 G-1TM v5 PLUS is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3

Source page: https://510kreport.com/device/K081114
Methodology: https://510kreport.com/methodology