CHLOE BLAST is an AI-enabled medical device from Fairtility Ltd., listed by FDA (510(k), K243851) with a decision date of 2025-08-15. Review panel: Obstetrics and Gynecology.
| FDA submission number | K243851 |
|---|---|
| Pathway | 510(k) |
| Company | Fairtility Ltd. |
| Review panel (specialty) | Obstetrics and Gynecology |
| FDA decision date | 2025-08-15 |
| Decision | Substantially Equivalent |
| Product code | PBH |
| Classification | Embryo Image Assessment System, Assisted Reproduction |
| Device class | 2 |
| Regulation number | 884.6195 |
| Review time (calendar days) | 242 |
| Applicant country | IL |
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.