# K041284: Medicult Ivm System

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Nov 22, 2004 after 193 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). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K053646: Invitro Maturation Media (2006), 0 descendants of its own

## Indications for use
Vial 1: The LAG Medium is for pre-incubation of immature oocytes. Vial 2: IVM® Medium is a basal medium for maturing immature oocytes with supplements "The LAG medium is for pre-incubation of immature oocytes and the IVM Medium is a basal medium for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons can not undergo conventional ovarian stimulation using drugs."

Source page: https://510kreport.com/device/K041284
Methodology: https://510kreport.com/methodology