# K241095: ARTSMedia Semen Wash Medium

- Pathway: 510(k) (Traditional)
- Applicant: Artsmedia Denmark Aps
- Decided: Dec 18, 2024 after 240 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: 4 generations back to K002383 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212410: VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium, Shenzhen Vitavitro Biotech Co., Ltd. (2022) Summary page 5.

## Indications for use
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).

Source page: https://510kreport.com/device/K241095
Methodology: https://510kreport.com/methodology