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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 K253701
Device Name SmartGuard Technology; Predictive Low Glucose Technology
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325
Applicant Contact Shivani Shah
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325
Correspondent Contact Shivani Shah
Regulation Number862.1356
Classification Product Code
QJI  
Subsequent Product Codes
NDC   QJS  
Date Received11/24/2025
Decision Date 02/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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