Cleared Traditional

T1D1

K252104 · Comerge AG · Chemistry
Aug 2025
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K252104 is an FDA 510(k) clearance for the T1D1, a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Comerge AG (Zurich, CH). The FDA issued a Cleared decision on August 20, 2025, 48 days after receiving the submission on July 3, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K252104 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2025
Decision Date August 20, 2025
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NDC — Calculator, Drug Dose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890