Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA product code KDI · Class II (moderate risk) · 21 CFR 876.5860 · Gastroenterology, Urology
345510(k) clearances
0PMA approvals
187recalls
Manufacturers
- Baxter Healthcare Corp 26
- Nxstage Medical, Inc. 26
- Hospal Medical Corp. 20
- Fresenius Medical Care Renal Therapies Group, LLC 19
- Gambro Renal Products 18
- Althin Medical AB an Affiliate of Baxter Intl 18
- Fresenius Medical Care North America 17
- Gambro, Inc. 15
- Chf Solutions, Inc. 11
- Minntech Corp. 11
- Outset Medical, Inc. 9
- Amicon, Inc. 8
- Nipro Medical Corporation 8
- Cobe Renal Care, Inc. 8
- Gambro Healthcare 7
- Fresenius USA, Inc. 6
- Seratronics, Inc. 6
- C.G.H. Medical, Inc. 5
- Asahi Medical Co., Ltd. 5
- Asahi Kasei Medical Co., Ltd. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 07/24/2026SE |
| K252377 | NxStage System One with NxViewKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/15/2026SE |
| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/10/2026SE |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | Outset Medical, Inc. | 01/26/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 12/18/2025SE |
| K243920 | Purema H Hemoconcentrator - PediatricKDI · Traditional | Medica USA, Inc. | 09/19/2025SE |
| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)KDI · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14…KDI · Traditional | Sorin Group Italia S.R.L. | 04/25/2025SE |
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 03/21/2025SE |
| K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/28/2025SE |
| K233798 | Moda-flx Hemodialysis System and CartridgeKDI · Traditional | Diality, Inc. | 08/02/2024SE |
| K233557 | HemoCare Hemodialysis SystemKDI · Traditional | Deka Research and Development | 07/12/2024SE |
| K240394 | multiFlux 1000 (F00012408)KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 05/31/2024SE |
| K232776 | Tablo® Hemodialysis System; TabloCart with Prefiltration DrawerKDI · Traditional | Outset Medical, Inc. | 05/03/2024SE |
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)KDI · Traditional | Nxstage Medical, Inc. | 03/14/2024SE |
| K232171 | Purema® H Hemoconcentrator (EtO Sterilized)KDI · Traditional | Tecnoideal America | 02/07/2024SE |
| K231534 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care | 02/02/2024SE |
| K231125 | 2008T BlueStar Hemodialysis MachineKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/06/2023SE |
| K233335 | Tablo® Hemodialysis SystemKDI · Traditional | Outset Medical, Inc. | 12/05/2023SE |
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis MachineKDI · Special | Baxter Healthcare Corporation | 09/14/2023SE |
| K230632 | VersiHD with GuideMe softwareKDI · Traditional | Nxstage Medical, Inc. | 08/11/2023SE |
| K223248 | Tablo® Hemodialysis SystemKDI · Traditional | Outset Medical, Inc. | 06/21/2023SE |
| K231406 | ClearumTM HSKDI · Special | Bellco Srl | 06/14/2023SE |
| K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/11/2023SE |
| K220281 | multiFiltratePRO SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/16/2022SE |
| K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDI · Traditional | Quanta Dialysis Technologies, Ltd. | 11/10/2022SE |
| K222952 | 2008T BlueStar Hemodailysis MachineKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/27/2022SE |
| K211370 | Tablo Hemodialysis SystemKDI · Traditional | Outset Medical, Inc. | 07/29/2022SE |
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution FilterKDI · Traditional | Nephros | 05/13/2022SE |
| K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setKDI · Traditional | Baxter Healthcare Corporation | 04/01/2022SE |
| K213639 | Revaclear 500, Revaclear 400, Revaclear 300KDI · Traditional | Baxter Healthcare Corporation | 01/24/2022SE |
| K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetKDI · Traditional | Quanta Dialysis Technologies, Ltd. | 08/12/2021SE |
| K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryKDI · Traditional | Baxter Healthcare Corportation | 03/10/2021SE |
| K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NRKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/28/2020SE |
| K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetKDI · Traditional | Quanta Dialysis Technologies, Ltd. | 12/23/2020SE |
| K193542 | Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22KDI · Traditional | Bellco Srl | 10/08/2020SE |
| K192707 | Optiflux F180NR DialyzerKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/21/2020SE |
| K193005 | DIMI RRT SystemKDI · Traditional | Dialco Medical, Inc. | 08/28/2020SE |
| K192928 | Optiflux Enexa F500 DialyzerKDI · Traditional | Fresenius Medical Care Reanal Therapies Group, LLC | 07/09/2020SE |
| K200741 | Tablo Hemodialysis SystemKDI · Traditional | Outset Medical, Inc. | 03/31/2020SE |
| K193482 | PrisMax System Version 3KDI · Traditional | Baxter Healthcare Corporation | 03/13/2020SE |
| K192756 | Aquadex FlexFlow System 2.0KDI · Traditional | Chf Solutions, Inc. | 02/24/2020SE |
| K190793 | Tablo Hemodialysis System, Tablo CartridgeKDI · Traditional | Outset Medical, Inc. | 12/12/2019SE |
| K183158 | NxStage Cartridge Express with SpeedswapKDI · Traditional | Nxstage Medical, Inc. | 08/09/2019SE |
| K190910 | PrisMax System Version 2KDI · Traditional | Baxter Healthcare Corp | 07/25/2019SE |
| K182940 | Surdial DX Hemodialysis SystemKDI · Traditional | Nipro Medical Corporation | 07/19/2019SE |
| K173972 | 2008T BlueStar Hemodialysis MachineKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/10/2018SE |
| K171671 | Prismaflex System 8.10KDI · Traditional | Baxter Healthcare Corporation | 02/23/2018SE |
| K170790 | SAM CRRT Unit, SAM Cassette CRRTKDI · Abbreviated | Spectral Medical, Inc. | 12/13/2017SE |
| K171331 | NxStage System OneKDI · Traditional | Nxstage Medical, Inc. | 08/24/2017SE |
| K170574 | Diacap Pro DialyzerKDI · Traditional | B. Braun Avitum AG | 08/11/2017SE |
| K170469 | NxStage System One PlusKDI · Traditional | Nxstage Medical, Inc. | 05/09/2017SE |
| K163530 | PrisMax Control UnitKDI · Traditional | Baxter Healthcare Corp | 05/03/2017SE |
| K162248 | Asahi ViE-U Series DialyzerKDI · Traditional | Asahi Kasei Medical Co., Ltd. | 05/03/2017SE |
| K162488 | Optiflux dialyzerKDI · Traditional | Fresenius Medical Care North America | 04/06/2017SE |
| K160444 | FB-U HemodialyzerKDI · Traditional | Nipro Medical Corporation | 02/08/2017SE |
| K160558 | Rapido Hollow-Fibre DialyzersKDI · Traditional | Bellco Srl | 11/18/2016SE |
| K160881 | Tablo ConsoleKDI · Traditional | Outset Medical, Inc. | 11/15/2016SE |
| K153449 | 2008K2 Hemodialysis MachineKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/26/2016SE |
| K152938 | DBB-06 Hemodialysis Delivery SystemKDI · Traditional | Nikkiso Co., Ltd. | 03/18/2016SE |
| K143482 | xevonta dialyzerKDI · Traditional | B. Braun Avitum AG | 03/01/2016SE |
| K153344 | Asahi REXEED-S Series DialyzerKDI · Special | Asahi Kasei Medical Co., Ltd. | 12/17/2015SE |
| K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/10/2015SE |
| K152367 | Optiflux dialyzerKDI · Traditional | Fresenius Medical Care North America | 10/29/2015SE |
| K150880 | Tablo Console with Wireless CapabilityKDI · Special | Outset Medical | 05/01/2015SE |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) CartridgeKDI · Traditional | Nxstage Medical, Inc. | 03/20/2015SE |
| K140866 | Tablo ConsoleKDI · Traditional | Home Dialysis Plus | 09/10/2014SE |
| K133299 | Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand AssemblyKDI · Traditional | Fresenius Medical Care, North America - Renal Ther | 07/07/2014SE |
| K140526 | Nxstage System OneKDI · Traditional | Nxstage Medical, Inc. | 05/19/2014SE |
| K140191 | Elisio-H HemodialyzerKDI · Special | Nipro Medical Corporation | 04/14/2014SE |
| K133547 | Nxstage System One with NxviewKDI · Traditional | Nxstage Medical, Inc. | 03/03/2014SE |
| K132602 | Streamline ExpressKDI · Traditional | Nxstage Medical, Inc. | 02/04/2014SE |
| K123262 | Optiflux Ultra DialyzerKDI · Traditional | Fresenius Medical Care North America | 01/06/2014SE |
| K131516 | Prismaflex System 7.10KDI · Traditional | Gambro Renal Products, Inc. | 01/03/2014SE |
| K131050 | Nxstage 1.6M2 DialyzerKDI · Traditional | Nxstage Medical, Inc. | 12/27/2013SE |
| K131935 | Elisio-H Hemodialyzer, Elisio-M HemodialyzerKDI · Special | Nipro Medical Corporation | 12/20/2013SE |
| K131381 | Elisio-H HemodialyzerKDI · Special | Nipro Medical Corporation | 12/19/2013SE |
| K131908 | 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/11/2013SE |
| K123288 | HemoconcentratorKDI · Traditional | Maquet Cardiopulmonary, AG | 06/26/2013SE |
| K122343 | Pureflux-H HemodialyzerKDI · Traditional | Nipro Medical Corporation | 05/07/2013SE |
| K130039 | Revaclear 300 Dialyzer, Revaclear 400 DialyzerKDI · Traditional | Gambro Renal Products, Inc. | 05/02/2013SE |
| K122347 | Elisio-H and Elisio-M HemodialyzersKDI · Traditional | Nipro Medical Corporation | 05/01/2013SE |
| K122051 | Nxstage System OneKDI · Special | Nxstage Medical, Inc. | 04/23/2013SE |
| K123395 | Nxstage System One Low Volume Cartridge ExpressKDI · Traditional | Nxstage Medical, Inc. | 03/07/2013SE |
| K121409 | Asahi Rexeed-Sx/Lx Series DialyzerKDI · Traditional | Asahi Kasei Medical Co., Ltd. | 02/06/2013SE |
| K113023 | Streamline Airless System Set with Pre-Attached DialyzerKDI · Traditional | Nxstage Medical, Inc. | 12/21/2012SE |
| K121341 | Fresenius 2008T Hemodialysis Machine with Bibag SystemKDI · Traditional | Fresenius Medical Care North America | 12/06/2012SE |
| K121497 | Venofer PumpKDI · Traditional | Renal Solutions, Inc. | 08/17/2012SE |
| K112314 | Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterKDI · Traditional | Nephros, Inc. | 04/27/2012SE |
| K120505 | Fresenius 2008T Hemodialysis MachineKDI · Special | Fresenius Medical Care North America, Design Cente | 03/06/2012SE |
| K120017 | Fresenius 2008 Hemodiaysis Machine with Bibag SystemKDI · Special | Fresenius Medical Care North America | 02/02/2012SE |
| K113427 | Fresenius 2008T Hemodialysis MachineKDI · Special | Fresenius Medical Care North America | 12/21/2011SE |
| K111639 | Fresenius 2008T Hemodialysis MachineKDI · Special | Fresenius Medical Care | 10/21/2011SE |
| K110823 | PrismaflexKDI · Traditional | Gambro Renal Products, Inc. | 06/17/2011SE |
| K103832 | Phoenix Hemodialysis Delivery SystemKDI · Traditional | Gambro Renal Products, Inc. | 05/20/2011SE |
| K103564 | Venofer PumpKDI · Special | Renal Solutions, Inc. | 02/10/2011SE |
| K101715 | Fresenius 2008T Hemodialysis Machine Model 190573KDI · Traditional | Fresenius Medical Care North America, Design Cente | 12/21/2010SE |
| K093069 | Nxstage System One with Therapeutic Plasma Exchange CartridgeKDI · Traditional | Nxstage Medical, Inc. | 10/23/2010SE |
| K093964 | Venofer PumpKDI · Abbreviated | Renal Solutions, Inc. | 07/09/2010SE |
| K093902 | Modification To:Fresenius 2008T Hemodialysis Machine, Model 190573KDI · Special | Fresenius Medical Care North America | 05/27/2010SE |
| K100334 | Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811KDI · Special | B. Braun Avitum AG | 04/22/2010SE |
| K091978 | DBB-06 Hemodialysis Delivery SystemKDI · Traditional | Nikkiso Co., Ltd. | 03/25/2010SE |
| K083460 | Dialog with Adimea OptionKDI · Traditional | B. Braun Avitum AG | 02/18/2010SE |
| K093120 | Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170KDI · Special | Baxter Healthcare Corporation - Renal Division | 02/17/2010SE |
| K093379 | Tcx-I-Dv Remote Care Management SystemKDI · Traditional | Bl Healthcare, Inc. | 02/09/2010SE |
| K090682 | Edwards Aquarius System, Model GE-F098-00KDI · Special | Edwards Lifesciences Services GmbH | 11/19/2009SE |
| K083158 | Exalis, Software Version 1.15KDI · Traditional | Gambro, Inc. | 06/05/2009SE |
| K083778 | Xenium XPH, Models 110, 130, 150, 170, 190 and 210KDI · Special | Baxter Healthcare Corporation | 02/20/2009SE |
| K080964 | Fresenius Model 2008T Hemodialysis MachineKDI · Special | Fresenius Medical Care North America | 01/14/2009SE |
| K080650 | Omni-Dl SystemKDI · Traditional | Transvivo, Inc. | 11/26/2008SE |
| K081313 | SH14 HemoconcentratorKDI · Abbreviated | Sorin Group Italia S.R.L. | 11/19/2008SE |
| K082414 | Optiflux F250NR, Model 0500325EKDI · Traditional | Fresenius Medical Care North America | 10/28/2008SE |
| K082515 | Asahi Rexeed-Sx/Lx Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LXKDI · Special | Asahi Kasei Medical Co., Ltd. | 10/03/2008SE |
| K080519 | Prismaflex M150 SetKDI · Traditional | Gambro Renal Products, Inc. | 06/13/2008SE |
| K072093 | Prismaflex System, Version 3.20KDI · Traditional | Gambro | 02/01/2008SE |
| K070643 | Phoenix Hemodialysis Delivery System, Version 3.35KDI · Traditional | Gambro, Inc. | 11/02/2007SE |
| K061519 | Modification to DBB-05 Hemodialysis Delivery SystemKDI · Special | Nikkiso Co., Ltd. | 09/28/2007SE |
| K072232 | Gambro Polyflux Hemodialyzer, Model: HD-C4 SmallKDI · Special | Gambro Renal Products, Inc. | 09/07/2007SE |
| K071854 | Aquadex Flexflow SystemKDI · Special | Chf Solutions, Inc. | 09/07/2007SE |
| K071263 | Nxstage Travel Warmer, Models TW-400 & FWS-500KDI · Traditional | Nxstage Medical, Inc. | 08/24/2007SE |
| K071518 | Diacap Lo PS (10, 12, 15) and Diacap Hi PS (10, 12, 15, 18, 20) HemodialyzersKDI · Traditional | B. Braun Medizintechnologie GmbH | 08/17/2007SE |
| K071298 | HF Junior HemofilterKDI · Traditional | Minntech Corp. | 08/08/2007SE |
| K070320 | Edwards Aquarius Hemofiltration System, Model Abm 01KDI · Traditional | Edwards Lifesciences Services GmbH | 06/07/2007SE |
| K070512 | Modification to Aquadex Flexflow SystemKDI · Special | Chf Solutions, Inc. | 04/27/2007SE |
| K070222 | Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610NKDI · Traditional | Fresenius Medical Care North America | 04/24/2007SE |
| K063183 | Prisma M10 Pre SetKDI · Traditional | Gambro Renal Products, Inc. | 02/15/2007SE |
| K062922 | Modification to Aquadex Flexflow SystemKDI · Special | Chf Solutions, Inc. | 12/13/2006SE |
| K062079 | Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210KDI · Traditional | Baxter Healthcare Corporation | 10/19/2006SE |
| K062090 | Prisma System R03.10AKDI · Traditional | Gambro Renal Products | 10/18/2006SE |
| K061837 | Nxstage Cartridge ExpressKDI · Special | Nxstage Medical, Inc. | 07/31/2006SE |
| K053539 | Meridian Hemodialysis Machine, Model 5M5576KDI · Traditional | Baxter Healthcare Corporation | 05/24/2006SE |
| K060195 | Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single UseKDI · Traditional | Gambro Renal Products | 04/24/2006SE |
| K060008 | Aquadex Flexflow SystemKDI · Special | Chf Solutions, Inc. | 02/02/2006SE |
| K050952 | HPH Junior High Performance HemoconcentratorKDI · Traditional | Minntech Corp. | 01/31/2006SE |
| K051520 | Gambro Polyflux Hemodialyzer, Model 6HKDI · Traditional | Gambro Renal Products | 12/09/2005SE |
| K050609 | Aquadex SystemKDI · Traditional | Chf Solutions, Inc. | 11/09/2005SE |
| K050525 | Nxstage System OneKDI · Traditional | Nxstage Medical, Inc. | 06/24/2005SE |
| K050727 | Modification to Nxstage Cartridge ExpressKDI · Special | Nxstage Medical, Inc. | 06/13/2005SE |
| K050603 | Olpur Dialyzer, Model HD 190KDI · Traditional | Nephros, Inc. | 06/09/2005SE |
| K051187 | Rexeed Series DialyzersKDI · Special | Asahi Kasei Medical Co., Ltd. | 06/08/2005SE |
| K042938 | Gambro Prismaflex HF1000 and HF1400 SetsKDI · Special | Gambro Renal Products | 01/06/2005SE |
| K043244 | Fresenius Optiflux F20NR, FF18NR, F16NRKDI · Special | Fresenius Medical Care North America | 12/20/2004SE |
| K041005 | Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsKDI · Abbreviated | Gambro Renal Products | 10/07/2004SE |
| K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…KDI · Special | Asahi Medical Co., Ltd. | 07/23/2004SE |
| K041424 | Nxstage System OneKDI · Traditional | Nxstage Medical, Inc. | 07/02/2004SE |
| K040696 | Modification to Nxstage System OneKDI · Special | Nxstage Medical, Inc. | 05/26/2004SE |
| K040255 | Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseKDI · Special | Gambro Renal Products, Inc. | 05/24/2004SE |
| K040489 | Aquadex System 100, Model A1100KDI · Special | Chf Solutions, Inc. | 04/27/2004SE |
| K034064 | Fresenius Ultraflo HPX HemodialyzerKDI · Special | Fresenius Medical Care North America | 01/30/2004SE |
| K023874 | System 100 Ultrafiltration CatheterKDI · Traditional | Chf Solutions, Inc. | 11/20/2003SE |
| K023509 | DBB-05 Hemodialysis Delivery SystemKDI · Traditional | Davita Clinical Research (Trri) | 10/30/2003SE |
| K032356 | Nxstage System One with Cartridge ExpressKDI · Traditional | Nxstage Medical, Inc. | 10/28/2003SE |
| K030050 | Toraysulfone Dialyzer, Bs-L SeriesKDI · Traditional | Toray Industries (America), Inc. | 09/29/2003SE |
| K032431 | Prisma M60/M100 SetsKDI · Special | Gambro, Inc. | 09/15/2003SE |
| K030099 | Baxter Arena Hemodialysis Delivery System, Model 1571278000KDI · Traditional | Baxter Healthcare Corp | 06/17/2003SE |
| K031378 | Fresenius Ultraflux HemodialyzerKDI · Special | Fresenius Medical Care North America | 05/30/2003SE |
| K030592 | Gambro Polyflux, Model 140H, 170H, 210HKDI · Traditional | Gambro Renal Care Products | 05/23/2003SE |
| K030975 | Exeltra Plus High Flux Dialyzer, Model 210KDI · Special | Baxter Healthcare Corp | 04/25/2003SE |
| K030974 | Exeltra High Flux Dialyzer, Models 150 & 170KDI · Special | Baxter Healthcare Corp | 04/25/2003SE |
| K024124 | System 100-UF 500 Circuit with In-Line Needleless Access PortKDI · Traditional | Chf Solutions, Inc. | 03/14/2003SE |
| K023664 | Syntra + Dialyzer, Model 200KDI · Traditional | Baxter Healthcare Corp | 02/21/2003SE |
| K013562 | Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys…KDI · Traditional | Baxter Healthcare Corp | 12/12/2002SE |
| K014152 | Nxstage Cartridge ExpressKDI · Traditional | Nxstage Medical, Inc. | 12/11/2002SE |
| K021615 | Baxter Accura System, Model 5M5660KDI · Traditional | Baxter Healthcare Corp | 11/18/2002SE |
| K021732 | DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6…KDI · Traditional | Dideco S.P.A. | 11/04/2002SE |
| K023224 | Infusion Catheter Extension SetKDI · Special | Chf Solutions, Inc. | 10/25/2002SE |
| K010805 | Prisma SystemKDI · Abbreviated | Gambro Renal Products | 08/06/2002SE |
| K013418 | Am-Bio Extended Range Series Dialyzer, Models Wet and DryKDI · Traditional | Asahi Medical Co., Ltd. | 07/09/2002SE |
| K013733 | System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetKDI · Traditional | Chf Solutions, Inc. | 06/03/2002SE |
| K020858 | Nxstage Therapy SystemKDI · Special | Nxstage Medical, Inc. | 04/17/2002SE |
| K010131 | PHD Personal Hemodialysis INSTRUMENT-1M101, PHD Water Pre-Treatment KIT-1W605,PHD Hard…KDI · Traditional | Aksys, Ltd. | 03/26/2002SE |
| K011269 | Lifemate Mla Multi-Line Adaptor; Lifemate SFR Sterile Fluid ReservoirKDI · Traditional | Nxstage Medical, Inc. | 03/04/2002SE |
| K011537 | Dynamic Hollow Fiber Dialyzer Ds-Series, Model: Polysulfone 100 HFS, Polysulfone 130 HFSKDI · Traditional | Dynamic Technology Corp. | 01/07/2002SE |
| K013550 | Clirans E-Series DialyzerKDI · Special | Terumo Medical Corp. | 11/20/2001SE |
| K011221 | Prisma HF 1000 Set, Prisma HF 1000 Pre-SetKDI · Traditional | Gambro Renal Products | 10/31/2001SE |
| K012510 | Modification to: Lifemate Hemofiltration SystemKDI · Special | Nxstage Medical, Inc. | 10/19/2001SE |
| K002512 | Toraysulfone DialyzerKDI · Traditional | Toray Industries (America), Inc. | 10/15/2001SE |
| K010985 | Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10LKDI · Traditional | Gambro Renal Products | 10/10/2001SE |
| K010667 | Gambro Polyflux 24S, Gambro Polyflux 24RKDI · Traditional | Gambro Renal Products | 06/04/2001SE |
| K003023 | Cobe HC 700 Midi HemoconcentratorKDI · Traditional | Hospal Industrie | 04/30/2001SE |
| K000724 | Medica HP 300 Hemofiltration Pump, Model 300KDI · Traditional | Medica S.R.L. | 03/22/2001SE |
| K002210 | Syntra Dialyzer, Model Syntra 120, 160KDI · Traditional | Baxter Healthcare Corp | 02/14/2001SE |
| K003425 | Clirans E-Series Hollow Fiber DialyzersKDI · Traditional | Terumo Medical Corp. | 02/01/2001SE |
| K001283 | Lifemate Hemofiltration SystemKDI · Traditional | Nxstage Medical, Inc. | 01/17/2001SE |
| K003498 | Fresenius Optiflux 200AKDI · Special | Fresenius Medical Care North America | 01/04/2001SE |
| K994198 | Hemofeel-Ch, Models CH-0.35L, CH-0.6L, CH-1.0LKDI · Traditional | Toray Industries (America), Inc. | 08/25/2000SE |
| K002277 | Fresenius Optiflux 200NRKDI · Special | Fresenius Medical Care North America | 08/25/2000SE |
| K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)KDI · Traditional | Asahi Medical Co., Ltd. | 08/16/2000SE |
| K001156 | Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing SetKDI · Abbreviated | Gambro Renal Products | 07/07/2000SE |
| K001422 | PSN Hemodialyzer, Models PSN 170, PSN 210KDI · Special | Baxter Healthcare Corp | 06/02/2000SE |
| K000028 | Renaflo II HF 2000 HemofilterKDI · Traditional | Minntech Corp. | 04/04/2000SE |
| K994267 | Fresenius 2008KKDI · Traditional | Fresenius Medical Care | 03/16/2000SE |
| K992573 | AF-220 HemodialyzerKDI · Traditional | Althin Medical AB | 01/18/2000SE |
| K992566 | AF-150 HemodialyzerKDI · Traditional | Althin Medical AB | 01/18/2000SE |
| K992564 | AF-180 HemodialyzerKDI · Traditional | Althin Medical AB | 01/18/2000SE |
| K992563 | A-22 HemodialyzerKDI · Traditional | Althin Medical AB | 01/18/2000SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3017-2026 Class II | Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126…Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no… | Fresenius Medical Care Renal Therapies… | 06/30/2026Open, Classified |
| Z-2702-2026 Class II | 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and…Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset… | Fresenius Medical Care Holdings, Inc. | 05/11/2026Open, Classified |
| Z-1230-2026 Class II | PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without…There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Vantive US Healthcare LLC | 01/06/2026Open, Classified |
| Z-1229-2026 Class II | PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without…There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Vantive US Healthcare LLC | 01/06/2026Open, Classified |
| Z-1228-2026 Class II | PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without…There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Vantive US Healthcare LLC | 01/06/2026Open, Classified |
| Z-1227-2026 Class II | PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without…There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Vantive US Healthcare LLC | 01/06/2026Open, Classified |
| Z-1226-2026 Class II | OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed…There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Vantive US Healthcare LLC | 01/06/2026Open, Classified |
| Z-1225-2026 Class II | PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or…There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Vantive US Healthcare LLC | 01/06/2026Open, Classified |
| Z-1224-2026 Class II | PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or…There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. | Vantive US Healthcare LLC | 01/06/2026Open, Classified |
| Z-0912-2026 Class II | Hemodialysis System, Surdial DX REF: MC+SDX01 Rx OnlyScrew may loosen or fallout of Hemodialysis system | Nipro Medical Corporation | 10/27/2025Open, Classified |
| Z-0936-2026 Class II | 5008X CAREsystem +CLiC +CDX;Several software anomalies with the potential to impact patient treatment, of which one includes the… | Fresenius Medical Care Holdings, Inc. | 10/25/2025Open, Classified |
| Z-2439-2025 Class II | TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702…Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to… | Vantive US Healthcare LLC | 07/28/2025Open, Classified |
| Z-2438-2025 Class II | PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty… | Vantive US Healthcare LLC | 07/28/2025Open, Classified |
| Z-2437-2025 Class II | PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in… | Vantive US Healthcare LLC | 07/28/2025Open, Classified |
| Z-1992-2025 Class II | 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models:…Potential of blood leak occurring between the lower port of the venous chamber and the tubing include:… | Fresenius Medical Care Holdings, Inc. | 04/29/2025Open, Classified |
| Z-0831-2025 Class I | nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal…The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow… | Nuwellis Inc | 12/11/2024Completed |
| Z-0801-2025 Class II | Dialyzer Optiflux 160NRePotential for internal blood leaks due to cracked polyurethane | Fresenius Medical Care Holdings, Inc. | 12/05/2024Open, Classified |
| Z-0327-2025 Class I | Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of…Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to… | Baxter Healthcare Corporation | 10/16/2024Open, Classified |
| Z-3124-2024 Class II | Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware…Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version… | Fresenius Medical Care Holdings, Inc. | 08/08/2024Open, Classified |
| Z-0019-2025 Class II | Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The…Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level… | Outset Medical, Inc. | 08/01/2024Open, Classified |
| Z-2347-2024 Class II | RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 06/03/2024Open, Classified |
| Z-2346-2024 Class II | RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 06/03/2024Open, Classified |
| Z-2345-2024 Class II | RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number:…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 06/03/2024Open, Classified |
| Z-2344-2024 Class II | RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 06/03/2024Open, Classified |
| Z-2343-2024 Class II | 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 06/03/2024Open, Classified |
| Z-2342-2024 Class II | 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 06/03/2024Open, Classified |
| Z-2341-2024 Class II | 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number:…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 06/03/2024Open, Classified |
| Z-2340-2024 Class II | 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 06/03/2024Open, Classified |
| Z-2150-2024 Class II | TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot)…A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female… | Outset Medical, Inc. | 04/30/2024Open, Classified |
| Z-1870-2024 Class II | 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 04/17/2024Open, Classified |
| Z-1869-2024 Class II | 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 04/17/2024Open, Classified |
| Z-1868-2024 Class II | 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 04/17/2024Open, Classified |
| Z-1867-2024 Class II | 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor…An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 04/17/2024Open, Classified |
| Z-1866-2024 Class II | Blood Pump Rotor, Model Number: F40015481 Rev AAn increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a… | Fresenius Medical Care Holdings, Inc. | 04/17/2024Open, Classified |
| Z-1485-2024 Class I | Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage… | Outset Medical, Inc. | 03/06/2024Open, Classified |
| Z-1191-2024 Class II | NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for…Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If… | NxStage MDS Corporation | 01/29/2024Open, Classified |
| Z-0035-2024 Class I | 2008T HD SYS. W/O CDX W/BIBAG BLUESTARPotential PCBA leaching from tubing of hemodialysis machines. | Fresenius Medical Care Holdings, Inc. | 09/06/2023Open, Classified |
| Z-0034-2024 Class I | 2008T HD SYS. W/O CDX BLUESTARPotential PCBA leaching from tubing of hemodialysis machines. | Fresenius Medical Care Holdings, Inc. | 09/06/2023Open, Classified |
| Z-0033-2024 Class I | 2008T HD SYS. CDX W/BIBAG BLUESTARPotential PCBA leaching from tubing of hemodialysis machines. | Fresenius Medical Care Holdings, Inc. | 09/06/2023Open, Classified |
| Z-0032-2024 Class I | 2008T HD SYS. CDX BLUESTARPotential PCBA leaching from tubing of hemodialysis machines. | Fresenius Medical Care Holdings, Inc. | 09/06/2023Open, Classified |
| Z-0031-2024 Class I | 2008T GEN 2 Bibag without CDXPotential PCBA leaching from tubing of hemodialysis machines. | Fresenius Medical Care Holdings, Inc. | 09/06/2023Open, Classified |
| Z-0030-2024 Class I | 2008T Hemodialysis System w/BibagPotential PCBA leaching from tubing of hemodialysis machines. | Fresenius Medical Care Holdings, Inc. | 09/06/2023Open, Classified |
| Z-0029-2024 Class I | 2008T Hemodialysis System without CDXPotential PCBA leaching from tubing of hemodialysis machines. | Fresenius Medical Care Holdings, Inc. | 09/06/2023Open, Classified |
| Z-0028-2024 Class I | 2008T Hemodialysis SYS, with CDXPotential PCBA leaching from tubing of hemodialysis machines. | Fresenius Medical Care Holdings, Inc. | 09/06/2023Open, Classified |
| Z-0764-2023 Class II | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by…Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Baxter Healthcare Corporation | 11/23/2022Open, Classified |
| Z-0763-2023 Class II | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by…Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Baxter Healthcare Corporation | 11/23/2022Open, Classified |
| Z-0762-2023 Class II | Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by…Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Baxter Healthcare Corporation | 11/23/2022Open, Classified |
| Z-0761-2023 Class II | Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat…Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer | Baxter Healthcare Corporation | 11/23/2022Open, Classified |
| Z-0760-2023 Class II | Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal…Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer | Baxter Healthcare Corporation | 11/23/2022Open, Classified |
| Z-0085-2023 Class II | Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid…Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian… | Baxter Healthcare Corporation | 09/14/2022Open, Classified |