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FDA 510(k)

BioticsAI

K-Number: K250959 · 2025-12-22

ApplicantBioticsai, Inc.
Decision Date2025-12-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BioticsAI is a medical device manufactured by Bioticsai, Inc.. It received FDA 510(k) clearance on 2025-12-22 under approval number K250959. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioticsAI?

BioticsAI is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Bioticsai, Inc.. The 510(k) number is K250959.

When was BioticsAI approved by the FDA?

BioticsAI received FDA 510(k) clearance on 2025-12-22, under approval number K250959.

What company makes BioticsAI?

BioticsAI is manufactured by Bioticsai, Inc..

What is the FDA product code for BioticsAI?

The FDA product code for BioticsAI is IYN.

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Official Source

View on FDA Database →

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

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