510(k) Report

Devices descending from K001604

4 later devices reach Dana Diabecare through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071418Dana 3CC Syringe Insulin ReservoirSooil Development Co., Ltd.20070—
+1K022317Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-ST, &…Sooil Development Co., Ltd.20021—
+1K013807Microjet Quark, Model U100 or U40Cane S.R.L.20010—
+2K063126Dana Diabecare IisSooil Development Co., Ltd.20070—