# K111715: Embryoscope

- Pathway: 510(k) (Traditional)
- Applicant: Unisense Fertilitech A/S
- Decided: Aug 11, 2011 after 52 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: 3 generations back to K040717 (2004). 4 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092183: Embryoscope and Embryoslide, Unisense Fertilitech A/S (2011) Summary page 1.

## Most influential descendants
- K113075: Embryo Viewer Software (2011), 8 descendants of its own
- K133712: Embryoviewer Software (2014), 4 descendants of its own
- K173264: EmbryoScope+ (2018), 3 descendants of its own
- K171736: Geri Embryo Incubator and Geri Dish (2017), 2 descendants of its own
- K242684: Harioculture TL-16 Time-lapse Incubator (2025), 0 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 inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.

Source page: https://510kreport.com/device/K111715
Methodology: https://510kreport.com/methodology