# K040717: Nunc Ivf Multidish 4 Wells Nunclon

- Pathway: 510(k) (Traditional)
- Applicant: Nunc A/S
- Decided: Aug 12, 2004 after 146 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.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices 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.

## Most influential descendants
- K070047: Nunc Ivf Dishes and Nunc Ivf 4-Well Dish (2007), 12 descendants of its own
- K092183: Embryoscope and Embryoslide (2011), 11 descendants of its own
- K111715: Embryoscope (2011), 9 descendants of its own
- K113075: Embryo Viewer Software (2011), 8 descendants of its own
- K150961: EmbryoSlide Culture Dish (2015), 4 descendants of its own

## Indications for use
The plate is a sterile non-pyrogenic, Embryotoxicity tested singleuse plasticware intended for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques, and cell culture

Source page: https://510kreport.com/device/K040717
Methodology: https://510kreport.com/methodology