510(k) Report

Devices descending from K201214

17 later devices reach t:slim X2 Insulin Pump with Interoperable Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223846iLet® ACE PumpBeta Bionics, Inc.20233—
+1K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc.202212Class I
+2K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.20236Class I
+2K223213Tandem Mobi Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.20234Class I
+2K231485iLet® ACE PumpBeta Bionics, Inc.202321
+3K252770iLet ACE PumpBeta Bionics, Inc.202512
+3K250792t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc.202501
+3K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.202546
+3K233044Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.20233Class I
+4K253976iLet ACE PumpBeta Bionics, Inc.20260—
+4K253743MiniMed Flex pumpMedtronic Minimed, Inc.202601
+4K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed20261—
+4K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.20260—
+4K240309Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.20242Class I
+5K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed20260—
+5K241078Tandem Mobi Insulin Pump with interoperable technologyTandem Diabetes Care, Inc.20241Class I
+6K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.202501