# K142147: Eeva System

- Pathway: 510(k) (Traditional)
- Applicant: Auxogyn, Inc.
- Decided: Nov 24, 2014 after 111 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: 1 generation back to DEN120015 (2014). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120015: EEVA 2.0, Auxogyn, Inc. (2014). Our reading of the summary gave K120427, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120015, EEVA 2.0 (Auxogyn, Inc.), granted Jun 6, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.
- DEN120015: EEVA 2.0, Auxogyn, Inc. (2014) Summary page 4.

## Most influential descendants
- K250781: Embryo Predict (2026), 0 descendants of its own
- K182798: KIDScore D3 (2019), 0 descendants of its own

## Indications for use
The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The device may also be used to collect additional time-lapse images until Day 5 of development for embryos not selected for transfer, to allow monitoring of continued embryo development.

Source page: https://510kreport.com/device/K142147
Methodology: https://510kreport.com/methodology