# K991279: Medi-Cult Universal Ivf-Medium

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Jul 20, 2000 after 463 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K061309: Embryoassist (2007), 3 descendants of its own
- K080473: Embryoassist and Embryoassist with Phenol Red (2008), 2 descendants of its own
- K120136: Embryogen (2012), 1 descendant of its own
- K041284: Medicult Ivm System (2004), 1 descendant of its own
- K140317: Embryogen (2014), 0 descendants of its own

## Indications for use
Medi-Cult Universal IVF Medium is used for the fertilization of human oocytes and culture of fertilized oocytes up to the 4-6-cell stage (day 2 after insemination). Medi-Cult Universal IVF Medium can also be used as vehicle during embryo transfer.

Source page: https://510kreport.com/device/K991279
Methodology: https://510kreport.com/methodology