510(k) Report

Devices descending from K201207

5 later devices reach CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+1K2315345008X Hemodialysis SystemFresenius Medical Care202421
+1K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC202311
+2K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+2K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.20250—