# K002836: Media for Gamete Preparation and Embryo Culture

- Pathway: 510(k) (Special)
- Applicant: Sage Biopharma
- Decided: Oct 3, 2000 after 21 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.
2 later devices descend from it; 2 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K173624: ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) (2018), 0 descendants of its own
- K053646: Invitro Maturation Media (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K002836
Methodology: https://510kreport.com/methodology