510(k) Report

Devices descending from K010264

31 later devices reach Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082719Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-PNikkiso CO., LTD.200913—
+1K072024Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219…Nipro Medical Corp.2007161
+2K231589Blood Tubing Lines for Hemodialysis AV06C-ENikkiso CO., LTD.20230—
+2K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…Nikkiso CO., LTD.20232—
+2K171952Dimesol Tubing Sets for HemodialysisDimesol, Inc.20180—
+2K161582DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.20174—
+2K150304Oxyless Blood Tubing SetOxyless, Ltd.20160—
+2K112628Nipro Blood Tubing Set with Transducer Protector and Priming SetNipro Medical Corporation201201
+2K120823BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer ProtectorsFresenius Medical Care North America, Design Cente20128—
+2K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125—
+2K072988Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation20081—
+3K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…Nikkiso CO., LTD.20250—
+3K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…Nikkiso CO., LTD.20250—
+3K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.20240—
+3K2315345008X Hemodialysis SystemFresenius Medical Care202421
+3K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros20221—
+3K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd.20210—
+3K201866NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.20212—
+3K140841Tablo CartridgeHome Dialysis Plus20147—
+4K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.20260—
+4K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.20260—
+4K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+4K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+4K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20203—
+4K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+5K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+5K210782Tablo CartridgeOutset Medical, Inc.20211—
+5K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.20212—
+6K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+6K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+6K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—