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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interoperable Automated Glycemic Controller
510(k) Number K261461
Device Name Omnipod 6 algorithm
Applicant
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Lavanya Ramnath
Correspondent
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Lavanya Ramnath
Regulation Number862.1356
Classification Product Code
QJI  
Date Received05/04/2026
Decision Date 06/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT06865989
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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