FDA 510(k)

Embryo Predict

K-Number: K250781 · 2026-05-15

Decision Date2026-05-15

Product CodePBH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Embryo Predict is the device name listed in this FDA 510(k) record. The listed applicant is Alife Health. It received FDA 510(k) clearance on 2026-05-15 under 510(k) 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. The listed applicant is Alife Health. The 510(k) number is K250781.

When did Embryo Predict receive FDA 510(k) clearance?

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

Who is the listed applicant for Embryo Predict?

The FDA 510(k) record lists Alife Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Embryo Predict?

The FDA product code for Embryo Predict is PBH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05483985Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for TransferCOMPLETED

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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.