# K080395: Sunivf Dishes - Pathway: 510(k) (Traditional) - Applicant: Intl., Inc. - Decided: Aug 13, 2008 after 182 days - Product code: MQK (Labware, Assisted Reproduction) - Device class: 2 - Regulation: 21 CFR 884.6160 - 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 The SunIVF UniversalTM Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional in-vitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation. The SunFVF Micromanipulation Tm Dish is intended to be used to hold human oocytes and embryos during in-vitro procedures of assisted human reproduction, including fertilization by intracytoplasmic sperm injection, assisted hatching, and biopsy. The SunIVF ICSFTm Dish is intended to be used to hold human oocytes and sperm during the procedure of fertilization by intracytoplasmic sperm injection. The SunIVF Freezing Dish 1 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation. The SunIVF Freezing Dish 2 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation. The SunIVF Vitrification Dish is intended to be used to hold human cocytes and embryos during the procedures of vitrification The SunIVF Rotational Dish is intended to be used to hold human oocytes and embryos during handling and culture. The SunlVF General Flat Dish - 35 X 10 mm is intended to be used for washing and handling of human oocytes and embryos. The SunlIVF General Flat Dish - 60 X 15 mm is intended to be used for washing and handling of human oocytes and embryos. The SunIVF General Flat Dish - 90 X 17 mm is intended to be used for washing and handling of human oocytes and embryos. Source page: https://510kreport.com/device/K080395 Methodology: https://510kreport.com/methodology