510(k) Report

Devices descending from K080807

9 later devices reach Blood Tubing Sets (Sterile Fluid Path) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC20176—
+1K132602Streamline ExpressNxstage Medical, Inc.20140—
+1K090255Blood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc.20090—
+2K2315345008X Hemodialysis SystemFresenius Medical Care202421
+2K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…Fresenius Medical Care Renal Therapies Group, LLC20205—
+3K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+3K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC202311
+4K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+4K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.20250—