# K250781: Embryo Predict

- Pathway: 510(k) (Traditional)
- Applicant: Alife Health
- Decided: May 15, 2026 after 427 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 5.

## Indications for use
Embryo Predict is indicated to analyze images of Day 5, 6, and 7 blastocyst-stage embryos (early, expanded, hatching, and hatched) cultured in vitro that have been deemed suitable for transfer by the embryologist. The device uses patient metadata (patient age, day of embryo culture) and a software algorithm to analyze features of the blastocyst morphology and provides adjunctive information to aid in the assessment of blastocysts when there are multiple embryos deemed suitable for transfer or freezing based on standard morphological assessment. The device is intended for analysis of blastocyst stage embryos prior to biopsy and cryopreservation.

Source page: https://510kreport.com/device/K250781
Methodology: https://510kreport.com/methodology