510(k) Report

Devices descending from DEN190034

17 later devices reach Control-IQ Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200467Control-IQ TechnologyTandem Diabetes Care, Inc.202015—
+1K193483Basal-IQ TechnologyTandem Diabetes Care, Inc.20200Class I
+2K232382Control-IQ TechnologyTandem Diabetes Care, Inc.202371
+2K220916iLet® Dosing Decision SoftwareBeta Bionics, Inc.20232—
+2K203689Tidepool LoopTidepool Project20232—
+2K203774SmartAdjust technologyInsulet Corporation20220—
+3K251152DBLG2Diabeloop20250—
+3K251217SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.20253—
+3K243823Control-IQ+ technologyTandem Diabetes Care, Inc.202521
+3K234055DEKA LoopDeka Research and Development20240—
+3K232224iLet® Dosing Decision SoftwareBeta Bionics, Inc.202311
+4K262763iLet Dosing Decision SoftwareBeta Bionics, Inc.20260—
+4K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed20261—
+4K253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.20260—
+4K250798Control-IQ+ technologyTandem Diabetes Care, Inc.202511
+5K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed20260—
+5K260429Control-IQ+ technologyTandem Diabetes Care, Inc.20260—