# K092183: Embryoscope and Embryoslide

- Pathway: 510(k) (Traditional)
- Applicant: Unisense Fertilitech A/S
- Decided: Jan 11, 2011 after 539 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- 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 K040717 (2004). 3 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983642: Cook Mini-Incubator, Cook Ob/Gyn (1999) Summary page 2.
- K070047: Nunc Ivf Dishes and Nunc Ivf 4-Well Dish, Nunc A/S (2007) Summary page 3.

## Most influential descendants
- 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
- K133712: Embryoviewer Software (2014), 4 descendants of its own
- K173264: EmbryoScope+ (2018), 3 descendants of its own

## Indications for use
To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to three days (72 hr) covering the time from post-fertilization to day 3 of development. Preparing, storing, and transferring human embryos. To be used only with the EmbryoScope device.

Source page: https://510kreport.com/device/K092183
Methodology: https://510kreport.com/methodology