- Device
- Embryo Predict
- Company
- Alife Health
- Submission number
- K250781
- Pathway
- 510(k)
- Decision date
- May 15, 2026
- Specialty (lead panel)
- Obstetrics and Gynecology
- Primary product code
- PBH
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.