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510(k) K253512

MiniMed Go App by Medtronic Minimed — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2026
Date Received
November 6, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

Other clearances by Medtronic Minimed

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  • K253585 — SmartGuard technology; Predictive Low Glucose technology (January 14, 2026)
  • K251217 — SmartGuard technology; Predictive Low Glucose technology (August 29, 2025)
  • K251032 — MiniMed 780G insulin pump (July 1, 2025)
  • K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (November 12, 2024)
  • K241622 — Extended Reservoir; MiniMed Reservoir (July 2, 2024)
  • K210714 — Extended Reservoir (April 6, 2022)
  • K160860 — MiniMed Quick-serter (September 22, 2016)

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  • K232451 — Insulia Bolus Companion (December 12, 2023)
  • K230813 — BlueStar and BlueStar Rx (July 28, 2023)
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  • K203434 — BlueStar Rx (September 8, 2021)