510(k) Report

Devices descending from K190487

10 later devices reach InPen Dose Calculator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232451Insulia Bolus CompanionVoluntis Sa.20230—
+1K201337InPen SystemCompanion Medical, Inc.202072
+1K193483Basal-IQ TechnologyTandem Diabetes Care, Inc.20200Class I
+2K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed202463
+3K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.20260—
+3K253512MiniMed Go AppMedtronic Minimed202602
+3K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.202546
+4K253743MiniMed Flex pumpMedtronic Minimed, Inc.202601
+4K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed20261—
+5K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed20260—