# K150756: Micro well group culture dish, 9-well; Micro well group culture dish, 16-well

- Pathway: 510(k) (Traditional)
- Applicant: Hertart
- Decided: Jul 20, 2015 after 119 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: 3 generations back to K990941 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123641: Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish, Icsi Dish, Hertart (2013) Summary page 4.

## Indications for use
For in-vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture

Source page: https://510kreport.com/device/K150756
Methodology: https://510kreport.com/methodology