# K182798: KIDScore D3

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife A/S
- Decided: Jul 19, 2019 after 290 days
- Product code: PBH (Embryo Image Assessment System, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6195
- 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 DEN120015 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142147: Eeva System, Auxogyn, Inc. (2014) Summary page 4.

## Indications for use
The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.

Source page: https://510kreport.com/device/K182798
Methodology: https://510kreport.com/methodology