# DEN120015: EEVA 2.0

- Pathway: De Novo (Post-NSE)
- Applicant: Auxogyn, Inc.
- Decided: Jun 6, 2014 after 651 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K142147: Eeva System (2014), 2 descendants of its own
- K250781: Embryo Predict (2026), 0 descendants of its own
- K243851: Chloe Blast (2025), 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.

Source page: https://510kreport.com/device/DEN120015
Methodology: https://510kreport.com/methodology