# K090429: Nunc Ivf Centerwell and Icsi Dishes

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific (Nalge Nunc Intl)
- Decided: Sep 18, 2009 after 211 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: 1 generation back to K990941 (1999). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990941: Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452L, Humagen Fertility Diagnostics, Inc. (1999) Summary page 1.

## Most influential descendants
- K112413: RI MSC (Migration Sedimentation Chamber) (2012), 7 descendants of its own
- K133295: Qualis (2014), 5 descendants of its own
- K173075: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) (2018), 4 descendants of its own
- K123641: Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish, Icsi Dish (2013), 1 descendant of its own
- K241626: SperSort™ Sperm Sorting Chip (IPG02) (2025), 0 descendants of its own

## Indications for use
The IVF Center Well Dish is intended for preparing and culturing gametes or embryos for use in human In Vitro Fertilization (IVF).

Source page: https://510kreport.com/device/K090429
Methodology: https://510kreport.com/methodology