FDA 510(k)

T1D1

K-Number: K252104 · 2025-08-20

Decision Date2025-08-20

Product CodeNDC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

T1D1 is the device name listed in this FDA 510(k) record. The listed applicant is Comerge AG. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K252104. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T1D1?

T1D1 is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Comerge AG. The 510(k) number is K252104.

When did T1D1 receive FDA 510(k) clearance?

T1D1 received FDA 510(k) clearance on 2025-08-20, under 510(k) number K252104.

Who is the listed applicant for T1D1?

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

What is the FDA product code for T1D1?

The FDA product code for T1D1 is NDC.

Other records listing Comerge AG 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.

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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.