# K053646: Invitro Maturation Media

- Pathway: 510(k) (Traditional)
- Applicant: Sage In-Vitro Fertilization, Inc.
- Decided: Jul 14, 2006 after 196 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 K991279 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041284: Medicult Ivm System, Medicult A/S (2004) Summary page 2.
- K002836: Media for Gamete Preparation and Embryo Culture, Sage Biopharma (2000) Summary page 2.

## Indications for use
System for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons cannot or choose not to undergo conventional ovarian stimulation using drugs. Oocyte Washing Medium: This medium is used for washing immature oocytes contained within cumulus-oocyte complexes (COCs), collected from the follicles before maturation in culture. Oocvte Maturation Medium: This medium is used for maturation in culture of immature oocytes in an incubator. Embryo Maintenance: This medium is used for embryonic culture following insemination by intracytoplasmic sperm injection (ICSI).

Source page: https://510kreport.com/device/K053646
Methodology: https://510kreport.com/methodology