# K080473: Embryoassist and Embryoassist with Phenol Red

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Sep 3, 2008 after 195 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: 2 generations back to K000625 (2000). 6 ancestors in all.
2 later devices descend 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)
- K991279: Medi-Cult Universal Ivf-Medium, Medicult A/S (2000) Summary page 1.
- K061309: Embryoassist, Medicult A/S (2007) Summary page 1.
- K030490: ISM1+, IMS2+, and Utm+, Medicult A/S (2003) Summary page 1.

## Most influential descendants
- K120136: Embryogen (2012), 1 descendant of its own
- K140317: Embryogen (2014), 0 descendants of its own

## Indications for use
EmbryoAssist TM with Phenol Red is for fertilization and culture until the 2-8 cell stage. EmbryoAssist TM with Phenol Red can also be used for embryo transfer at day 2 or 3. EmbryoAssist TM is for fertilization and culture until the 2-8 cell stage. EmbryoAssist TM can also be used for embryo transfer at day 2 or 3.

Source page: https://510kreport.com/device/K080473
Methodology: https://510kreport.com/methodology