510(k) Report

Devices descending from K203234

12 later devices reach t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.20236Class I
+1K223213Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.20234Class I
+2K250792t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc.202501
+2K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.202546
+2K233044Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.20233Class I
+3K253743MiniMed Flex pumpMedtronic Minimed, Inc.202601
+3K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed20261—
+3K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.20260—
+3K240309Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.20242Class I
+4K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed20260—
+4K241078Tandem Mobi Insulin Pump with interoperable technologyTandem Diabetes Care, Inc.20241Class I
+5K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.202501