# K140317: Embryogen

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Jun 16, 2014 after 126 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: 4 generations back to K000625 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120136: Embryogen, Origio A/S (2012) Summary page 1.

## Indications for use
EmbryoGen® is for culture of human embryos until the 2-8 cell stage. EmbryoGen® can also be used for embryo transfer at day 2 or 3.

Source page: https://510kreport.com/device/K140317
Methodology: https://510kreport.com/methodology