510(k) Report

Devices descending from K160629

21 later devices reach InPen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222689Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production20224—
+1K212217Tempo Smart ButtonEli Lilly and Company20221—
+1K190487InPen Dose CalculatorCompanion Medical, Inc.2020101
+1K192841InPen SystemCompanion Medical, Inc.202001
+1K181327InPen Dose CalculatorCompanion Medical, Inc.20181—
+2K243901SmartPilot YpsoMate NS-A2.25Ypsomed AG20250—
+2K252104T1D1Comerge AG20250—
+2K241803INSULCLOCK® v2.0 PROInsulcloud S.L.20240—
+2K231820SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production20242—
+2K232451Insulia Bolus CompanionVoluntis Sa.20230—
+2K201337InPen SystemCompanion Medical, Inc.202072
+2K193483Basal-IQ TechnologyTandem Diabetes Care, Inc.20200Class I
+3K250555MallyaD injection pen adapter (MallyaD)Biocorp Production20251—
+3K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed202463
+4K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.20260—
+4K253512MiniMed Go AppMedtronic Minimed202602
+4K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.202546
+4K251500MallyaG Injection Pen Adapter (MallyaG)Biocorp Production20250—
+5K253743MiniMed Flex pumpMedtronic Minimed, Inc.202601
+5K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed20261—
+6K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed20260—