# K220715: ARTSMedia In Vitro Culture Medium (AM-IVC Medium)

- Pathway: 510(k) (Traditional)
- Applicant: Artsmedia Denmark Aps
- Decided: Feb 10, 2023 after 336 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 K112083 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133707: Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements, Origio A/S (2014) Summary page 4.

## Indications for use
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.

Source page: https://510kreport.com/device/K220715
Methodology: https://510kreport.com/methodology