# K991173: Fertilization Media-HTF - Pathway: 510(k) (Traditional) - Applicant: Intl., Inc. - Decided: Jul 19, 1999 after 103 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 K861188 (1987). 3 ancestors in all. No later device cites it as a predicate yet. 0 of 4 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K962816: Sperm Preparation Media, Genx Intl., Inc. (1996) Summary page 2. - K872102: Sperm Washing Medium #9932, Irvine Scientific (1987) Summary page 2. ## Cited in the summary but kept off the family tree - K861166: Oxygen Therapy Regulator or Regulator-Flowmeter, Victor (1986). Our OCR of the scanned summary read K861166, FDA’s number for Oxygen Therapy Regulator or Regulator-Flowmeter (Victor). Its FDA name has none of the distinctive words the summary uses for the device it names, “Irvine Capacitation Media”. Kept off the family tree. Summary page 2. ## Indications for use HTF Media is used as a general purpose media. May be used in procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (1Ul). It may also be used as a holding media at the time of retrieval of the gametes and for the holding of the oocytes in day 1 and 2, prior to transfer. 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/K991173 Methodology: https://510kreport.com/methodology