510(k) Report

Devices descending from K910215

14 later devices reach Drake Willock System 1000 Dialysate Delivery Syst through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013562Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys…Baxter Healthcare Corp200202
+1K970446Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl1997115
+1K964922Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery…Althin Medical AB an Affiliate of Baxter Intl19971—
+1K954987Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl1996131
+2K993064Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products199991
+3K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH200711
+3K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp200283
+4K090682Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH20090—
+4K063293Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards…Edwards Lifesciences Services GmbH20070—
+4K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products200447
+5K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+5K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+5K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+6K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—