# K040530: Media Culture System - Pathway: 510(k) (Traditional) - Applicant: Intl., Inc. - Decided: Jun 25, 2004 after 116 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. No later device cites it as a predicate yet. 0 of 1 device in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. FDA’s file for it is a 510(k) statement, which names no predicate. ## Indications for use HTF with HEPES is used as a holding media for human gametes and embryos for assisted reproduction. Global with HEPES is used as a holding and transfer medium for human gametes and embryos for assisted reproduction. PGD Biopsy Media is used as a holding medium for human gametes and embryos for assisted reproduction during the cell biopsy procedure used for pre-implantation genetic diagnosis. Source page: https://510kreport.com/device/K040530 Methodology: https://510kreport.com/methodology