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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alternate Controller Enabled Insulin Infusion Pump
510(k) Number K203768
Device Name Omnipod 5 ACE Pump (Pod)
Applicant
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Alexander Hamad
Correspondent
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Alexander Hamad
Regulation Number880.5730
Classification Product Code
QFG  
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
Recalls CDRH Recalls
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