510(k) Report

Devices descending from K231125

4 later devices reach 2008T BlueStar Hemodialysis Machine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2432372008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…Fresenius Medical Care Renal Therapies Group, LLC202501
+1K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+1K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD.20250—
+2K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—