# K991022: Sperm Washing Media - Pathway: 510(k) (Traditional) - Applicant: Intl., Inc. - Decided: Sep 9, 1999 after 164 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. The FDA summary names no predicate by number. ## Indications for use Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (1Ul). The indications for use of this media is based on the general procedures for preparation of semen for Intrauterine Insemination described by Paul S. Weatherbee, Ph.D. and Lawrence B. Werlin, M.D., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of California, Irvine Medical Center. Source page: https://510kreport.com/device/K991022 Methodology: https://510kreport.com/methodology