# K241132: ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

- Pathway: 510(k) (Traditional)
- Applicant: Artsmedia Denmark Aps
- Decided: Dec 18, 2024 after 238 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 K991327 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991327: Medi-Cult Flushing Medium, Medicult A/S (2000) Summary page 5.

## Indications for use
ARTSMedia Oocyte Aspiration Medium (AM-Oocyte Aspiration) is intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes.

Source page: https://510kreport.com/device/K241132
Methodology: https://510kreport.com/methodology