# K120136: Embryogen

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Sep 26, 2012 after 253 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: 3 generations back to K000625 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080473: Embryoassist and Embryoassist with Phenol Red, Medicult A/S (2008) Summary page 1.

## Most influential descendants
- K140317: Embryogen (2014), 0 descendants of its own

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

Source page: https://510kreport.com/device/K120136
Methodology: https://510kreport.com/methodology