FDA 510(k)

CogNet AI-MT+

K-Number: K252482 · 2025-12-11

Decision Date2025-12-11

Product CodeQFM

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CogNet AI-MT+ is the device name listed in this FDA 510(k) record. The listed applicant is Medcognetics, Inc.. It received FDA 510(k) clearance on 2025-12-11 under 510(k) number K252482. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CogNet AI-MT+?

CogNet AI-MT+ is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is Medcognetics, Inc.. The 510(k) number is K252482.

When did CogNet AI-MT+ receive FDA 510(k) clearance?

CogNet AI-MT+ received FDA 510(k) clearance on 2025-12-11, under 510(k) number K252482.

Who is the listed applicant for CogNet AI-MT+?

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

What is the FDA product code for CogNet AI-MT+?

The FDA product code for CogNet AI-MT+ is QFM.

Other records listing Medcognetics, Inc. as applicant

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.

K220080CogNet QmTRIAGE

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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.