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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 K251217
Device Name SmartGuard technology; Predictive Low Glucose technology
Applicant
Medtronic Minimed, Inc.
18000 Devonshire St.
Northridge,  CA  91325
Applicant Contact Hemang Kotecha
Correspondent
Medtronic Minimed, Inc.
18000 Devonshire St.
Northridge,  CA  91325
Correspondent Contact Hemang Kotecha
Regulation Number862.1356
Classification Product Code
QJI  
Subsequent Product Code
QJS  
Date Received04/21/2025
Decision Date 08/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01991470
NCT02130284
NCT02246582
NCT02463097
NCT02660827
NCT03966911
NCT04436822
NCT05714059
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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