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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Glucose Monitor Informed Insulin Dose Calculator
510(k) Number K252818
Device Name Dexcom Smart Basal
Applicant
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Neeta Sharma
Correspondent
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Dhara Sanjaykumar Desai
Regulation Number862.1358
Classification Product Code
QRX  
Date Received09/04/2025
Decision Date 11/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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