Embryo Predict— 510(k) K250781
Substantially EquivalentAlife Health
FDA 510(k) clearance K250781 for Embryo Predict, Substantially Equivalent on 2026-05-15. Applicant: Alife Health. Device class: 2.
Summary
Alife Health's Embryo Predict is filed under PBH, embryo image assessment systems for assisted reproduction.
Class II, 21 CFR 884.6195. Obstetrics/Gynecology is both the classification panel and the review panel, and it was a Traditional 510(k).
Alife Health filed from Cambridge, Massachusetts. Review took 427 calendar days (March 14, 2025 to May 15, 2026).
Clearance details
- Applicant
- Alife Health
- Product code
- Product code PBH
- Device class
- Class 2
- Regulation
- 21 CFR 884.6195
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Recent devices under product code PBH
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