FDA 510(k) Applications for Medical Device Product Code "KDI"
(Dialyzer, High Permeability With Or Without Sealed Dialysate System)

FDA 510(k) Number Applicant Device Name Decision Date
K010131 AKSYS, LTD. PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB 03/26/2002
K992563 ALTHIN MEDICAL AB A-22 HEMODIALYZER 01/18/2000
K992566 ALTHIN MEDICAL AB AF-150 HEMODIALYZER 01/18/2000
K992564 ALTHIN MEDICAL AB AF-180 HEMODIALYZER 01/18/2000
K992573 ALTHIN MEDICAL AB AF-220 HEMODIALYZER 01/18/2000
K954987 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM 08/08/1996
K970446 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM 06/02/1997
K964922 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM 05/21/1997
K955384 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION 01/10/1997
K990643 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 12/07/1999
K153344 Asahi Kasei Medical Co., Ltd. Asahi REXEED-S Series Dialyzer 12/17/2015
K082515 ASAHI KASEI MEDICAL CO., LTD. ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX 10/03/2008
K121409 ASAHI KASEI MEDICAL CO., LTD. ASAHI REXEED-SX/LX SERIES DIALYZER 02/06/2013
K162248 ASAHI KASEI MEDICAL CO., LTD. Asahi ViE-U Series Dialyzer 05/03/2017
K051187 ASAHI KASEI MEDICAL CO., LTD. REXEED SERIES DIALYZERS 06/08/2005
K013418 ASAHI MEDICAL CO., LTD AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY 07/09/2002
K001250 ASAHI MEDICAL CO., LTD. APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) 08/16/2000
K041726 ASAHI MEDICAL CO., LTD. HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX 07/23/2004
K100334 B. BRAUN AVITUM AG DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 04/22/2010
K170574 B. Braun Avitum AG Diacap Pro Dialyzer 08/11/2017
K083460 B. BRAUN AVITUM AG DIALOG WITH ADIMEA OPTION 02/18/2010
K143482 B. Braun Avitum AG xevonta dialyzer 03/01/2016
K963440 B. BRAUN MEDICAL AG DIALOG DIALYSIS MACHINE 06/26/1998
K973322 B. BRAUN MEDICAL, INC. DIAPACT CRRT 11/10/1998
K071518 B. BRAUN MEDIZINTECHNOLOGIE GMBH DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS 08/17/2007
K163530 BAXTER HEALTHCARE CORP PrisMax Control Unit 05/03/2017
K190910 Baxter Healthcare Corp PrisMax System Version 2 07/25/2019
K013562 BAXTER HEALTHCARE CORP. AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE 12/12/2002
K021615 BAXTER HEALTHCARE CORP. BAXTER ACCURA SYSTEM, MODEL 5M5660 11/18/2002
K030099 BAXTER HEALTHCARE CORP. BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 06/17/2003
K963203 BAXTER HEALTHCARE CORP. BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT 03/25/1997
K970591 BAXTER HEALTHCARE CORP. BLOOD MONITOR PUMP 09/09/1997
K974652 BAXTER HEALTHCARE CORP. BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER 07/10/1998
K030974 BAXTER HEALTHCARE CORP. EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 04/25/2003
K030975 BAXTER HEALTHCARE CORP. EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 04/25/2003
K992894 BAXTER HEALTHCARE CORP. MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 11/24/1999
K980656 BAXTER HEALTHCARE CORP. PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 05/19/1998
K001422 BAXTER HEALTHCARE CORP. PSN HEMODIALYZER, MODELS PSN 170, PSN 210 06/02/2000
K023664 BAXTER HEALTHCARE CORP. SYNTRA + DIALYZER, MODEL 200 02/21/2003
K002210 BAXTER HEALTHCARE CORP. SYNTRA DIALYZER, MODEL SYNTRA 120, 160 02/14/2001
K232467 Baxter Healthcare Corporation CleanCart A, CleanCart C, AK 98 Hemodialysis Machine 09/14/2023
K053539 BAXTER HEALTHCARE CORPORATION MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 05/24/2006
K212216 Baxter Healthcare Corporation Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set 04/01/2022
K171671 Baxter Healthcare Corporation Prismaflex System 8.10 02/23/2018
K193482 Baxter Healthcare Corporation PrisMax System Version 3 03/13/2020
K213639 Baxter Healthcare Corporation Revaclear 500, Revaclear 400, Revaclear 300 01/24/2022
K062079 BAXTER HEALTHCARE CORPORATION XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 10/19/2006
K083778 BAXTER HEALTHCARE CORPORATION XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 02/20/2009
K093120 BAXTER HEALTHCARE CORPORATION - RENAL DIVISION XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 02/17/2010
K201809 Baxter Healthcare Corportation AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory 03/10/2021
K193542 Bellco Srl Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 10/08/2020
K231406 Bellco Srl ClearumTM HS 06/14/2023
K160558 BELLCO Srl RAPIDO HOLLOW-FIBRE DIALYZERS 11/18/2016
K093379 BL HEALTHCARE, INC. TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM 02/09/2010
K971180 C.R. BARD, INC. BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT 07/24/1997
K060008 CHF SOLUTIONS, INC. AQUADEX FLEXFLOW SYSTEM 02/02/2006
K071854 CHF SOLUTIONS, INC. AQUADEX FLEXFLOW SYSTEM 09/07/2007
K192756 CHF Solutions, Inc. Aquadex FlexFlow System 2.0 02/24/2020
K050609 CHF SOLUTIONS, INC. AQUADEX SYSTEM 11/09/2005
K040489 CHF SOLUTIONS, INC. AQUADEX SYSTEM 100, MODEL A1100 04/27/2004
K023224 CHF SOLUTIONS, INC. INFUSION CATHETER EXTENSION SET 10/25/2002
K062922 CHF SOLUTIONS, INC. MODIFICATION TO AQUADEX FLEXFLOW SYSTEM 12/13/2006
K070512 CHF SOLUTIONS, INC. MODIFICATION TO AQUADEX FLEXFLOW SYSTEM 04/27/2007
K023874 CHF SOLUTIONS, INC. SYSTEM 100 ULTRAFILTRATION CATHETER 11/20/2003
K024124 CHF SOLUTIONS, INC. SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT 03/14/2003
K013733 CHF SOLUTIONS, INC. SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET 06/03/2002
K955592 COBE RENAL CARE, INC. COBE CENTRYSYSTEM 14 PES HEMODIALYZERS 04/30/1997
K960474 COBE RENAL CARE, INC. COBE CENTRYSYSTEM 600 HG HEMODIALYZERS 08/14/1996
K951311 COBE RENAL CARE, INC. GAMBRO HC 14R HEMOCONCENTRATOR 01/11/1996
K955487 COBE RENAL CARE, INC. GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS 04/18/1997
K946279 COBE RENAL CARE, INC. PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) 02/10/1997
K023509 DAVITA CLINICAL RESEARCH (TRRI) DBB-05 HEMODIALYSIS DELIVERY SYSTEM 10/30/2003
K233557 Deka Research and Development HemoCare Hemodialysis System 07/12/2024
K193005 Dialco Medical Inc. DIMI RRT System 08/28/2020
K233798 Diality, Inc. Moda-flx Hemodialysis System and Cartridge 08/02/2024
K021732 DIDECO S.P.A. DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT 11/04/2002
K982134 DYNAMIC TECHNOLOGY CORP. DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 04/14/1999
K011537 DYNAMIC TECHNOLOGY CORP. DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS 01/07/2002
K070320 EDWARDS LIFESCIENCES SERVICES GMBH EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 06/07/2007
K090682 EDWARDS LIFESCIENCES SERVICES GMBH EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 11/19/2009
K231534 Fresenius Medical Care 5008X Hemodialysis System 02/02/2024
K994267 FRESENIUS MEDICAL CARE FRESENIUS 2008K 03/16/2000
K111639 FRESENIUS MEDICAL CARE FRESENIUS 2008T HEMODIALYSIS MACHINE 10/21/2011
K113427 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS 2008T HEMODIALYSIS MACHINE 12/21/2011
K982926 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS BLOOD VOLUME MONITOR 09/03/1999
K080964 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE 01/14/2009
K991520 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION 07/30/1999
K003498 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS OPTIFLUX 200A 01/04/2001
K002277 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS OPTIFLUX 200NR 08/25/2000
K043244 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR 12/20/2004
K070222 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N 04/24/2007
K034064 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS ULTRAFLO HPX HEMODIALYZER 01/30/2004
K031378 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS ULTRAFLUX HEMODIALYZER 05/30/2003
K093902 FRESENIUS MEDICAL CARE NORTH AMERICA MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 05/27/2010
K162488 FRESENIUS MEDICAL CARE NORTH AMERICA Optiflux dialyzer 04/06/2017
K152367 FRESENIUS MEDICAL CARE NORTH AMERICA Optiflux dialyzer 10/29/2015
K082414 FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX F250NR, MODEL 0500325E 10/28/2008
K123262 FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX ULTRA DIALYZER 01/06/2014
K120505 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE FRESENIUS 2008T HEMODIALYSIS MACHINE 03/06/2012
K101715 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 12/21/2010
K192928 Fresenius Medical Care Reanal Therapies Group LLC Optiflux Enexa F500 Dialyzer 07/09/2020
K150708 FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine 12/10/2015
K153449 FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 2008K2 Hemodialysis Machine 04/26/2016
K222952 Fresenius Medical Care Renal Therapies Group, LLC 2008T BlueStar Hemodailysis Machine 10/27/2022
K173972 Fresenius Medical Care Renal Therapies Group, LLC 2008T BlueStar Hemodialysis Machine 05/10/2018
K231125 Fresenius Medical Care Renal Therapies Group, LLC 2008T BlueStar Hemodialysis Machine 12/06/2023
K243237 Fresenius Medical Care Renal Therapies Group, LLC 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) 06/13/2025
K131908 FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) 10/11/2013
K243505 Fresenius Medical Care Renal Therapies Group, LLC 5008X Hemodialysis System 05/30/2025
K242053 Fresenius Medical Care Renal Therapies Group, LLC FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) 03/21/2025
K243874 Fresenius Medical Care Renal Therapies Group, LLC FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) 02/28/2025
K220721 Fresenius Medical Care Renal Therapies Group, LLC FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 05/11/2023
K220281 Fresenius Medical Care Renal Therapies Group, LLC multiFiltratePRO System 12/16/2022
K240394 Fresenius Medical Care Renal Therapies Group, LLC multiFlux 1000 (F00012408) 05/31/2024
K192707 Fresenius Medical Care Renal Therapies Group, LLC Optiflux F180NR Dialyzer 09/21/2020
K203062 Fresenius Medical Care Renal Therapies Group, LLC Optiflux Series of Dialyzers F160NR, F180NR, F200NR 12/28/2020
K120017 FRESENIUS MEDICAL CARE, NORTH AMERICA FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM 02/02/2012
K121341 FRESENIUS MEDICAL CARE, NORTH AMERICA FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM 12/06/2012
K133299 FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY 07/07/2014
K961465 FRESENIUS USA, INC. 2008H ON LINE CLEARANCE MONITOR 07/03/1997
K974584 FRESENIUS USA, INC. FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS 05/14/1998
K992275 FRESENIUS USA, INC. FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS 08/04/1999
K072093 GAMBRO PRISMAFLEX SYSTEM, VERSION 3.20 02/01/2008
K982413 GAMBRO HEALTHCARE COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS 04/21/1999
K982760 GAMBRO HEALTHCARE COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET 11/04/1998
K970253 GAMBRO HEALTHCARE COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET 09/26/1997
K962427 GAMBRO HEALTHCARE COBE CENTRYSYSTEM 700 HG HEMODIALYZER 09/20/1996
K982414 GAMBRO HEALTHCARE GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS 03/26/1999
K980386 GAMBRO HEALTHCARE HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) 02/24/1999
K981681 GAMBRO HEALTHCARE PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) 08/11/1998
K030592 GAMBRO RENAL CARE PRODUCTS GAMBRO POLYFLUX, MODEL 140H, 170H, 210H 05/23/2003
K993064 GAMBRO RENAL CARE PRODUCTS PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) 10/06/1999
K010985 GAMBRO RENAL PRODUCTS GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L 10/10/2001
K010667 GAMBRO RENAL PRODUCTS GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R 06/04/2001
K060195 GAMBRO RENAL PRODUCTS GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE 04/24/2006
K051520 GAMBRO RENAL PRODUCTS GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H 12/09/2005
K041005 GAMBRO RENAL PRODUCTS GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS 10/07/2004
K042938 GAMBRO RENAL PRODUCTS GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS 01/06/2005
K001156 GAMBRO RENAL PRODUCTS PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET 07/07/2000
K011221 GAMBRO RENAL PRODUCTS PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET 10/31/2001
K010805 GAMBRO RENAL PRODUCTS PRISMA SYSTEM 08/06/2002
K062090 GAMBRO RENAL PRODUCTS PRISMA SYSTEM R03.10A 10/18/2006
K072232 GAMBRO RENAL PRODUCTS, INC. GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL 09/07/2007
K103832 GAMBRO RENAL PRODUCTS, INC. PHOENIX HEMODIALYSIS DELIVERY SYSTEM 05/20/2011
K040255 GAMBRO RENAL PRODUCTS, INC. POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE 05/24/2004
K063183 GAMBRO RENAL PRODUCTS, INC. PRISMA M10 PRE SET 02/15/2007
K110823 GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX 06/17/2011
K080519 GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX M150 SET 06/13/2008
K131516 GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX SYSTEM 7.10 01/03/2014
K130039 GAMBRO RENAL PRODUCTS, INC. REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER 05/02/2013
K083158 GAMBRO, INC. EXALIS, SOFTWARE VERSION 1.15 06/05/2009
K070643 GAMBRO, INC. PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 11/02/2007
K032431 GAMBRO, INC. PRISMA M60/M100 SETS 09/15/2003
K140866 HOME DIALYSIS PLUS TABLO CONSOLE 09/10/2014
K003023 HOSPAL INDUSTRIE COBE HC 700 MIDI HEMOCONCENTRATOR 04/30/2001
K123288 MAQUET CARDIOPULMONARY AG HEMOCONCENTRATOR 06/26/2013
K000724 MEDICA S.R.L. MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 03/22/2001
K983085 MINNTECH CORP. HEMOCOR HPH 700 HEMOCONCENTRATOR 11/13/1998
K980859 MINNTECH CORP. HEMOCOR HPH MINI HEMOCONCENTRATOR 05/12/1998
K071298 MINNTECH CORP. HF JUNIOR HEMOFILTER 08/08/2007
K050952 MINNTECH CORP. HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR 01/31/2006
K962707 MINNTECH CORP. MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET 10/09/1996
K000028 MINNTECH CORP. RENAFLO II HF 2000 HEMOFILTER 04/04/2000
K210575 Nephros HDF Assist Mudule, HDF Infusion Set and Substitution Filter 05/13/2022
K112314 NEPHROS, INC. NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER 04/27/2012
K050603 NEPHROS, INC. OLPUR DIALYZER, MODEL HD 190 06/09/2005
K091978 NIKKISO CO. LTD. DBB-06 HEMODIALYSIS DELIVERY SYSTEM 03/25/2010
K061519 NIKKISO CO. LTD. MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM 09/28/2007
K953996 NIKKISO CO. LTD. NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS 03/19/1997
K242155 NIKKISO CO., LTD. DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) 05/15/2025
K152938 NIKKISO, CO.,LTD. DBB-06 Hemodialysis Delivery System 03/18/2016
K122347 NIPRO MEDICAL CORPORATION ELISIO-H AND ELISIO-M HEMODIALYZERS 05/01/2013
K140191 NIPRO MEDICAL CORPORATION ELISIO-H HEMODIALYZER 04/14/2014
K131381 NIPRO MEDICAL CORPORATION ELISIO-H HEMODIALYZER 12/19/2013
K131935 NIPRO MEDICAL CORPORATION ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER 12/20/2013
K160444 NIPRO MEDICAL CORPORATION FB-U Hemodialyzer 02/08/2017
K122343 NIPRO MEDICAL CORPORATION PUREFLUX-H HEMODIALYZER 05/07/2013
K182940 Nipro Medical Corporation Surdial DX Hemodialysis System 07/19/2019
K232803 NxStage Medical Inc. NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) 03/14/2024
K170469 NxStage Medical, Inc NxStage System One Plus 05/09/2017
K001283 NXSTAGE MEDICAL, INC. LIFEMATE HEMOFILTRATION SYSTEM 01/17/2001
K011269 NXSTAGE MEDICAL, INC. LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR 03/04/2002
K050727 NXSTAGE MEDICAL, INC. MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS 06/13/2005
K040696 NXSTAGE MEDICAL, INC. MODIFICATION TO NXSTAGE SYSTEM ONE 05/26/2004
K012510 NXSTAGE MEDICAL, INC. MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM 10/19/2001
K131050 NXSTAGE MEDICAL, INC. NXSTAGE 1.6M2 DIALYZER 12/27/2013
K014152 NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS 12/11/2002
K061837 NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS 07/31/2006
K183158 NxStage Medical, Inc. NxStage Cartridge Express with Speedswap 08/09/2019
K122051 NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 04/23/2013
K140526 NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 05/19/2014
K171331 NxStage Medical, Inc. NxStage System One 08/24/2017
K041424 NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 07/02/2004
K050525 NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE 06/24/2005
K123395 NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS 03/07/2013
K032356 NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS 10/28/2003
K133547 NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE WITH NXVIEW 03/03/2014
K093069 NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE 10/23/2010
K143313 NxStage Medical, Inc. NxStage Therapeutic Plasma Exchange (TPE) Cartridge 03/20/2015
K020858 NXSTAGE MEDICAL, INC. NXSTAGE THERAPY SYSTEM 04/17/2002
K071263 NXSTAGE MEDICAL, INC. NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 08/24/2007
K113023 NXSTAGE MEDICAL, INC. STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER 12/21/2012
K132602 NXSTAGE MEDICAL, INC. STREAMLINE EXPRESS 02/04/2014
K230632 NxStage Medical, Inc. VersiHD with GuideMe software 08/11/2023
K150880 Outset Medical Tablo Console with Wireless Capability 05/01/2015
K160881 OUTSET MEDICAL, INC. Tablo Console 11/15/2016
K200741 Outset Medical, Inc. Tablo Hemodialysis System 03/31/2020
K211370 Outset Medical, Inc. Tablo Hemodialysis System 07/29/2022
K190793 Outset Medical, Inc. Tablo Hemodialysis System, Tablo Cartridge 12/12/2019
K223248 Outset Medical, Inc. Tablo« Hemodialysis System 06/21/2023
K233335 Outset Medical, Inc. Tablo« Hemodialysis System 12/05/2023
K232776 Outset Medical, Inc. Tablo« Hemodialysis System; TabloCartÖ with Prefiltration Drawer 05/03/2024
K222067 Quanta Dialysis Technologies Ltd SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set 11/10/2022
K210661 Quanta Dialysis Technologies Ltd SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset 08/12/2021
K193670 Quanta Dialysis Technologies Ltd. SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set 12/23/2020
K093964 RENAL SOLUTIONS INC. VENOFER PUMP 07/09/2010
K121497 RENAL SOLUTIONS INC. VENOFER PUMP 08/17/2012
K103564 RENAL SOLUTIONS, INC. VENOFER PUMP 02/10/2011
K970739 RESEARCH MEDICAL, INC. RMI HEMOCONCENTRATOR PREFERENCE PACK 07/08/1997
K243264 Sorin Group Italia S.r.l. DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) 04/25/2025
K081313 SORIN GROUP ITALIA S.R.L. SH14 HEMOCONCENTRATOR 11/19/2008
K170790 Spectral Medical Inc. SAM CRRT Unit, SAM Cassette CRRT 12/13/2017
K232171 Tecnoideal America Purema« H Hemoconcentrator (EtO Sterilized) 02/07/2024
K973516 TERUMO MEDICAL CORP. CAPIOX HEMOCONCENTRATOR 01/30/1998
K013550 TERUMO MEDICAL CORP. CLIRANS E-SERIES DIALYZER 11/20/2001
K003425 TERUMO MEDICAL CORP. CLIRANS E-SERIES HOLLOW FIBER DIALYZERS 02/01/2001
K994198 TORAY INDUSTRIES (AMERICA), INC. HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L 08/25/2000
K002512 TORAY INDUSTRIES (AMERICA), INC. TORAYSULFONE DIALYZER 10/15/2001
K030050 TORAY INDUSTRIES (AMERICA), INC. TORAYSULFONE DIALYZER, BS-L SERIES 09/29/2003
K080650 TRANSVIVO INC. OMNI-DL SYSTEM 11/26/2008


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