510(k) Report

Devices descending from K991936

6 later devices reach 3.0 ML Reservoir, Model 103/193 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071418Dana 3CC Syringe Insulin ReservoirSooil Development Co., Ltd.20070—
+1K024056Sureset 3.0 ML Reservoir, Model 24-103Applied Diabetes Research, Incorporated20032—
+1K020655Deltec Insulin Infusion Pump and AccessoriesDeltec, Inc.200206
+1K013767Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an…Sterling Medivations, Inc.20012—
+2K051045Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30Spectrx, Inc.20051—
+2K041152Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332AApplied Diabetes Research, Inc.20040—