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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 K253743
Device Name MiniMed Flex pump
Applicant
Medtronic Minimed, Inc.
18000 Devonshire St.
Northridge,  CA  91325
Applicant Contact Omar Becerra
Correspondent
Medtronic Minimed, Inc.
18000 Devonshire St.
Northridge,  CA  91325
Correspondent Contact Omar Becerra
Regulation Number880.5730
Classification Product Code
QFG  
Date Received11/24/2025
Decision Date 03/12/2026
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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