510(k) Report

Devices descending from K010359

37 later devices reach Innovo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123766Novopen Echo, a Dial a Dose Insulin Delivery PenNovo Nordisk, Inc.2013281
+1K053563Humapen MemoirEli Lilly and Company20067—
+2K162602NovoPen EchoNovo Nordisk, Inc.201641
+2K160629InPenCompanion Medical, Inc.2016211
+2K150874NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Novo Nordisk, Inc.201551
+2K093065Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc.20106—
+3K243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA20241—
+3K222689Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production20224—
+3K212217Tempo Smart ButtonEli Lilly and Company20221—
+3K190487InPen Dose CalculatorCompanion Medical, Inc.2020101
+3K192841InPen SystemCompanion Medical, Inc.202001
+3K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Novo Nordisk, Inc.20183—
+3K181327InPen Dose CalculatorCompanion Medical, Inc.20181—
+3K111924Finesse Personal Insulin Delivery PatchCalibra Medical, Inc.20124—
+3K100947Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc.20105—
+4K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA20260—
+4K243901SmartPilot YpsoMate NS-A2.25Ypsomed AG20250—
+4K252104T1D1Comerge AG20250—
+4K241803INSULCLOCK® v2.0 PROInsulcloud S.L.20240—
+4K240961Disposable Pen Injector AssemblyWuxi Nest Biotechnology Co., Ltd.20241—
+4K240774Pen InjectorWuxi Nest Biotechnology Co., Ltd.20240—
+4K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA20242—
+4K231820SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production20242—
+4K232451Insulia Bolus CompanionVoluntis Sa.20230—
+4K201337InPen SystemCompanion Medical, Inc.202072
+4K193483Basal-IQ TechnologyTandem Diabetes Care, Inc.20200Class I
+4K163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH20173—
+5K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.20260—
+5K250555MallyaD injection pen adapter (MallyaD)Biocorp Production20251—
+5K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed202463
+6K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.20260—
+6K253512MiniMed Go AppMedtronic Minimed202602
+6K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.202546
+6K251500MallyaG Injection Pen Adapter (MallyaG)Biocorp Production20250—
+7K253743MiniMed Flex pumpMedtronic Minimed, Inc.202601
+7K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed20261—
+8K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed20260—