510(k) Report

Devices descending from K981681

27 later devices reach Prisma CFM (Continuous Fluid Management System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH200711
+1K050609Aquadex SystemChf Solutions, Inc.20055—
+1K040489Aquadex System 100, Model A1100Chf Solutions, Inc.20046—
+1K023874System 100 Ultrafiltration CatheterChf Solutions, Inc.20030—
+1K032431Prisma M60/M100 SetsGambro, Inc.200386
+1K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp200283
+1K013733System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetChf Solutions, Inc.200214—
+2K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc.20130—
+2K090682Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH20090—
+2K070222Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610NFresenius Medical Care North America20070—
+2K063293Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards…Edwards Lifesciences Services GmbH20070—
+2K060008Aquadex Flexflow SystemChf Solutions, Inc.20064—
+2K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products200447
+2K0417915.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc.20042—
+2K031689Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc.20033—
+2K024124System 100-UF 500 Circuit with in-Line Needleless Access PortChf Solutions, Inc.20031—
+2K023224Infusion Catheter Extension SetChf Solutions, Inc.20021—
+3K233515Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…Nuwellis, Inc.20231—
+3K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+3K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+3K062922Modification to Aquadex Flexflow SystemChf Solutions, Inc.20063—
+3K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+4K252226Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended…Nuwellis, Inc.20250—
+4K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—
+4K070512Modification to Aquadex Flexflow SystemChf Solutions, Inc.20072—
+5K071854Aquadex Flexflow SystemChf Solutions, Inc.20071—
+6K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc.20200Class I