Embryo Predict is an AI-enabled medical device from Alife Health, listed by FDA (510(k), K250781) with a decision date of 2026-05-15. Review panel: Obstetrics and Gynecology.
| FDA submission number | K250781 |
|---|---|
| Pathway | 510(k) |
| Company | Alife Health |
| Review panel (specialty) | Obstetrics and Gynecology |
| FDA decision date | 2026-05-15 |
| Decision | Substantially Equivalent |
| Product code | PBH |
| Classification | Embryo Image Assessment System, Assisted Reproduction |
| Device class | 2 |
| Regulation number | 884.6195 |
| Review time (calendar days) | 427 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Obstetrics and Gynecology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.