510(k) Report

Devices descending from K873279

13 later devices reach 8810 Pump-Pump Single Needle Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K955384Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen OptionAlthin Medical AB an Affiliate of Baxter Intl199712—
+2K013562Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys…Baxter Healthcare Corp200202
+2K970446Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl1997115
+3K993064Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products199991
+4K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH200711
+4K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp200283
+5K090682Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH20090—
+5K063293Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards…Edwards Lifesciences Services GmbH20070—
+5K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products200447
+6K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+6K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+6K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+7K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—