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FDA 510(k)

Embryo Predict

K-Number: K250781 · 2026-05-15

ApplicantAlife Health
Decision Date2026-05-15
Product CodePBH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Embryo Predict is a medical device manufactured by Alife Health. It received FDA 510(k) clearance on 2026-05-15 under approval number K250781. The device is classified under product code PBH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Embryo Predict?

Embryo Predict is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Alife Health. The 510(k) number is K250781.

When was Embryo Predict approved by the FDA?

Embryo Predict received FDA 510(k) clearance on 2026-05-15, under approval number K250781.

What company makes Embryo Predict?

Embryo Predict is manufactured by Alife Health.

What is the FDA product code for Embryo Predict?

The FDA product code for Embryo Predict is PBH.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.