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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 K203774
Device Name SmartAdjust technology
Applicant
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Alexander Hamad
Correspondent
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Katie Pacheco
Regulation Number862.1356
Classification Product Code
QJI  
Date Received12/23/2020
Decision Date 01/27/2022
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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