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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 K253470
Device Name MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
Applicant
Medtronic Minimed, Inc.
18000 Devonshire St.
Northridge,  CA  91325
Applicant Contact Amber Street
Correspondent
Medtronic Minimed, Inc.
18000 Devonshire St.
Northridge,  CA  91325
Correspondent Contact Amber Street
Regulation Number880.5730
Classification Product Code
QFG  
Date Received10/10/2025
Decision Date 01/15/2026
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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