# K061309: Embryoassist

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Feb 8, 2007 after 274 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 K991279 (2000). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 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.
- K003156: Blastassist System, Medicult A/S (2001) Summary page 1.

## Most influential descendants
- K080473: Embryoassist and Embryoassist with Phenol Red (2008), 2 descendants of its own
- K120136: Embryogen (2012), 1 descendant of its own
- K140317: Embryogen (2014), 0 descendants of its own

## Indications for use
EmbryoAssist Tm is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.

Source page: https://510kreport.com/device/K061309
Methodology: https://510kreport.com/methodology