510(k) Report

Devices descending from K082719

13 later devices reach Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231589Blood Tubing Lines for Hemodialysis AV06C-ENikkiso CO., LTD.20230—
+1K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…Nikkiso CO., LTD.20232—
+1K120823BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer ProtectorsFresenius Medical Care North America, Design Cente20128—
+2K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…Nikkiso CO., LTD.20250—
+2K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…Nikkiso CO., LTD.20250—
+2K140841Tablo CartridgeHome Dialysis Plus20147—
+3K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20203—
+3K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+4K210782Tablo CartridgeOutset Medical, Inc.20211—
+4K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.20212—
+5K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+5K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+5K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—