510(k) Report

Devices descending from K123766

28 later devices reach Novopen Echo, a Dial a Dose Insulin Delivery Pen through their predicates, nearest generation first.

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