# K123641: Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish, Icsi Dish - Pathway: 510(k) (Traditional) - Applicant: Hertart - Decided: Jul 3, 2013 after 219 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 Longest line of descent: 2 generations back to K990941 (1999). 6 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 8 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K991253: Falcon Ivf Round Dish, Becton Dickinson Labware (1999) Summary page 3. - K040717: Nunc Ivf Multidish 4 Wells Nunclon, Nunc A/S (2004) Summary page 1. - K090429: Nunc Ivf Centerwell and Icsi Dishes, Thermo Fisher Scientific (Nalge Nunc Intl) (2009) Summary page 5. - K991251: Falcon Ivf One Well Dish, Becton Dickinson Labware (1999) Summary page 6. - K993881: Genx Culture Dish, Intl., Inc. (2000) Summary page 7. ## Most influential descendants - K150756: Micro well group culture dish, 9-well; Micro well group culture dish, 16-well (2015), 0 descendants of its own ## Indications for use The Vitrolife Culture Dishes are Intended for IVF, suitable for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafalloplan transfer (GIFT), or other reproduction procedures. The Vltrolife 5 Well Culture Dish Is Intended for IVF, suitable for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques. The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm during fertilization via intracytoplasmic sperm Injection (ICSI). The Vitralife Micro Droplet Culture Dish Is Intended for IVF. It may be used with sperm and for the culturing of embryos using drop culture. Source page: https://510kreport.com/device/K123641 Methodology: https://510kreport.com/methodology