FDA 510(k)

BioticsAI

K-Number: K250959 · 2025-12-22

Decision Date2025-12-22

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BioticsAI is the device name listed in this FDA 510(k) record. The listed applicant is Bioticsai, Inc.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) 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. The listed applicant is Bioticsai, Inc.. The 510(k) number is K250959.

When did BioticsAI receive FDA 510(k) clearance?

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

Who is the listed applicant for BioticsAI?

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

What is the FDA product code for BioticsAI?

The FDA product code for BioticsAI is IYN.

Related Devices (Code: IYN)

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.

Official Source

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