FDA Product Code
FDA Product Code KDI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5860
510(k) Clearances — 345 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101715 | FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 | Fresenius Medical Care North America, Design Cente | 2010-12-21 | Traditional | PDF ↗ |
| K093069 | NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE | Nxstage Medical, Inc. | 2010-10-23 | Traditional | PDF ↗ |
| K093964 | VENOFER PUMP | Renal Solutions, Inc. | 2010-07-09 | Abbreviated | PDF ↗ |
| K093902 | MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 | Fresenius Medical Care North America | 2010-05-27 | Special | PDF ↗ |
| K100334 | DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 | B. Braun Avitum AG | 2010-04-22 | Special | PDF ↗ |
| K091978 | DBB-06 HEMODIALYSIS DELIVERY SYSTEM | NIKKISO CO., LTD. | 2010-03-25 | Traditional | PDF ↗ |
| K083460 | DIALOG WITH ADIMEA OPTION | B. Braun Avitum AG | 2010-02-18 | Traditional | PDF ↗ |
| K093120 | XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 | Baxter Healthcare Corporation - Renal Division | 2010-02-17 | Special | PDF ↗ |
| K093379 | TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM | Bl Healthcare, Inc. | 2010-02-09 | Traditional | PDF ↗ |
| K090682 | EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 | Edwards Lifesciences Services GmbH | 2009-11-19 | Special | PDF ↗ |
| K083158 | EXALIS, SOFTWARE VERSION 1.15 | Gambro, Inc. | 2009-06-05 | Traditional | PDF ↗ |
| K083778 | XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 | Baxter Healthcare Corporation | 2009-02-20 | Special | PDF ↗ |
| K080964 | FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE | Fresenius Medical Care North America | 2009-01-14 | Special | PDF ↗ |
| K080650 | OMNI-DL SYSTEM | Transvivo, Inc. | 2008-11-26 | Traditional | PDF ↗ |
| K081313 | SH14 HEMOCONCENTRATOR | Sorin Group Italia S.R.L. | 2008-11-19 | Abbreviated | PDF ↗ |
| K082414 | OPTIFLUX F250NR, MODEL 0500325E | Fresenius Medical Care North America | 2008-10-28 | Traditional | PDF ↗ |
| K082515 | ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX | Asahi Kasei Medical Co., Ltd. | 2008-10-03 | Special | PDF ↗ |
| K080519 | PRISMAFLEX M150 SET | Gambro Renal Products, Inc. | 2008-06-13 | Traditional | PDF ↗ |
| K072093 | PRISMAFLEX SYSTEM, VERSION 3.20 | Gambro | 2008-02-01 | Traditional | PDF ↗ |
| K070643 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 | Gambro, Inc. | 2007-11-02 | Traditional | PDF ↗ |
| K061519 | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM | NIKKISO CO., LTD. | 2007-09-28 | Special | PDF ↗ |
| K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL | Gambro Renal Products, Inc. | 2007-09-07 | Special | PDF ↗ |
| K071854 | AQUADEX FLEXFLOW SYSTEM | Chf Solutions, Inc. | 2007-09-07 | Special | PDF ↗ |
| K071263 | NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 | Nxstage Medical, Inc. | 2007-08-24 | Traditional | PDF ↗ |
| K071518 | DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS | B. Braun Medizintechnologie GmbH | 2007-08-17 | Traditional | PDF ↗ |
| K071298 | HF JUNIOR HEMOFILTER | Minntech Corp. | 2007-08-08 | Traditional | PDF ↗ |
| K070320 | EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 | Edwards Lifesciences Services GmbH | 2007-06-07 | Traditional | PDF ↗ |
| K070512 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEM | Chf Solutions, Inc. | 2007-04-27 | Special | PDF ↗ |
| K070222 | FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N | Fresenius Medical Care North America | 2007-04-24 | Traditional | PDF ↗ |
| K063183 | PRISMA M10 PRE SET | Gambro Renal Products, Inc. | 2007-02-15 | Traditional | PDF ↗ |
| K062922 | MODIFICATION TO AQUADEX FLEXFLOW SYSTEM | Chf Solutions, Inc. | 2006-12-13 | Special | PDF ↗ |
| K062079 | XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 | Baxter Healthcare Corporation | 2006-10-19 | Traditional | PDF ↗ |
| K062090 | PRISMA SYSTEM R03.10A | Gambro Renal Products | 2006-10-18 | Traditional | PDF ↗ |
| K061837 | NXSTAGE CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2006-07-31 | Special | PDF ↗ |
| K053539 | MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 | Baxter Healthcare Corporation | 2006-05-24 | Traditional | PDF ↗ |
| K060195 | GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE | Gambro Renal Products | 2006-04-24 | Traditional | PDF ↗ |
| K060008 | AQUADEX FLEXFLOW SYSTEM | Chf Solutions, Inc. | 2006-02-02 | Special | PDF ↗ |
| K050952 | HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR | Minntech Corp. | 2006-01-31 | Traditional | PDF ↗ |
| K051520 | GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H | Gambro Renal Products | 2005-12-09 | Traditional | PDF ↗ |
| K050609 | AQUADEX SYSTEM | Chf Solutions, Inc. | 2005-11-09 | Traditional | PDF ↗ |
| K050525 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2005-06-24 | Traditional | PDF ↗ |
| K050727 | MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2005-06-13 | Special | PDF ↗ |
| K050603 | OLPUR DIALYZER, MODEL HD 190 | Nephros, Inc. | 2005-06-09 | Traditional | PDF ↗ |
| K051187 | REXEED SERIES DIALYZERS | Asahi Kasei Medical Co., Ltd. | 2005-06-08 | Special | PDF ↗ |
| K042938 | GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS | Gambro Renal Products | 2005-01-06 | Special | PDF ↗ |
| K043244 | FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR | Fresenius Medical Care North America | 2004-12-20 | Special | PDF ↗ |
| K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS | Gambro Renal Products | 2004-10-07 | Abbreviated | PDF ↗ |
| K041726 | HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX | Asahi Medical Co., Ltd. | 2004-07-23 | Special | PDF ↗ |
| K041424 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2004-07-02 | Traditional | PDF ↗ |
| K040696 | MODIFICATION TO NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2004-05-26 | Special | PDF ↗ |
| K040255 | POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE | Gambro Renal Products, Inc. | 2004-05-24 | Special | PDF ↗ |
| K040489 | AQUADEX SYSTEM 100, MODEL A1100 | Chf Solutions, Inc. | 2004-04-27 | Special | PDF ↗ |
| K034064 | FRESENIUS ULTRAFLO HPX HEMODIALYZER | Fresenius Medical Care North America | 2004-01-30 | Special | PDF ↗ |
| K023874 | SYSTEM 100 ULTRAFILTRATION CATHETER | Chf Solutions, Inc. | 2003-11-20 | Traditional | PDF ↗ |
| K023509 | DBB-05 HEMODIALYSIS DELIVERY SYSTEM | Davita Clinical Research (Trri) | 2003-10-30 | Traditional | PDF ↗ |
| K032356 | NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2003-10-28 | Traditional | PDF ↗ |
| K030050 | TORAYSULFONE DIALYZER, BS-L SERIES | Toray Industries (America), Inc. | 2003-09-29 | Traditional | PDF ↗ |
| K032431 | PRISMA M60/M100 SETS | Gambro, Inc. | 2003-09-15 | Special | PDF ↗ |
| K030099 | BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 | Baxter Healthcare Corp | 2003-06-17 | Traditional | PDF ↗ |
| K031378 | FRESENIUS ULTRAFLUX HEMODIALYZER | Fresenius Medical Care North America | 2003-05-30 | Special | PDF ↗ |
| K030592 | GAMBRO POLYFLUX, MODEL 140H, 170H, 210H | Gambro Renal Care Products | 2003-05-23 | Traditional | PDF ↗ |
| K030974 | EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 | Baxter Healthcare Corp | 2003-04-25 | Special | PDF ↗ |
| K030975 | EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 | Baxter Healthcare Corp | 2003-04-25 | Special | PDF ↗ |
| K024124 | SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT | Chf Solutions, Inc. | 2003-03-14 | Traditional | PDF ↗ |
| K023664 | SYNTRA + DIALYZER, MODEL 200 | Baxter Healthcare Corp | 2003-02-21 | Traditional | PDF ↗ |
| K013562 | AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE | Baxter Healthcare Corp | 2002-12-12 | Traditional | PDF ↗ |
| K014152 | NXSTAGE CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2002-12-11 | Traditional | PDF ↗ |
| K021615 | BAXTER ACCURA SYSTEM, MODEL 5M5660 | Baxter Healthcare Corp | 2002-11-18 | Traditional | PDF ↗ |
| K021732 | DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT | Dideco S.P.A. | 2002-11-04 | Traditional | PDF ↗ |
| K023224 | INFUSION CATHETER EXTENSION SET | Chf Solutions, Inc. | 2002-10-25 | Special | PDF ↗ |
| K010805 | PRISMA SYSTEM | Gambro Renal Products | 2002-08-06 | Abbreviated | PDF ↗ |
| K013418 | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY | Asahi Medical Co., Ltd. | 2002-07-09 | Traditional | PDF ↗ |
| K013733 | SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET | Chf Solutions, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K020858 | NXSTAGE THERAPY SYSTEM | Nxstage Medical, Inc. | 2002-04-17 | Special | PDF ↗ |
| K010131 | PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB | Aksys, Ltd. | 2002-03-26 | Traditional | PDF ↗ |
| K011269 | LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR | Nxstage Medical, Inc. | 2002-03-04 | Traditional | PDF ↗ |
| K011537 | DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS | Dynamic Technology Corp. | 2002-01-07 | Traditional | PDF ↗ |
| K013550 | CLIRANS E-SERIES DIALYZER | Terumo Medical Corp. | 2001-11-20 | Special | PDF ↗ |
| K011221 | PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET | Gambro Renal Products | 2001-10-31 | Traditional | PDF ↗ |
| K012510 | MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM | Nxstage Medical, Inc. | 2001-10-19 | Special | PDF ↗ |
| K002512 | TORAYSULFONE DIALYZER | Toray Industries (America), Inc. | 2001-10-15 | Traditional | PDF ↗ |
| K010985 | GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L | Gambro Renal Products | 2001-10-10 | Traditional | PDF ↗ |
| K010667 | GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R | Gambro Renal Products | 2001-06-04 | Traditional | PDF ↗ |
| K003023 | COBE HC 700 MIDI HEMOCONCENTRATOR | Hospal Industrie | 2001-04-30 | Traditional | PDF ↗ |
| K000724 | MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 | Medica S.R.L. | 2001-03-22 | Traditional | PDF ↗ |
| K002210 | SYNTRA DIALYZER, MODEL SYNTRA 120, 160 | Baxter Healthcare Corp | 2001-02-14 | Traditional | PDF ↗ |
| K003425 | CLIRANS E-SERIES HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | 2001-02-01 | Traditional | PDF ↗ |
| K001283 | LIFEMATE HEMOFILTRATION SYSTEM | Nxstage Medical, Inc. | 2001-01-17 | Traditional | PDF ↗ |
| K003498 | FRESENIUS OPTIFLUX 200A | Fresenius Medical Care North America | 2001-01-04 | Special | PDF ↗ |
| K994198 | HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L | Toray Industries (America), Inc. | 2000-08-25 | Traditional | PDF ↗ |
| K002277 | FRESENIUS OPTIFLUX 200NR | Fresenius Medical Care North America | 2000-08-25 | Special | PDF ↗ |
| K001250 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) | Asahi Medical Co., Ltd. | 2000-08-16 | Traditional | PDF ↗ |
| K001156 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET | Gambro Renal Products | 2000-07-07 | Abbreviated | PDF ↗ |
| K001422 | PSN HEMODIALYZER, MODELS PSN 170, PSN 210 | Baxter Healthcare Corp | 2000-06-02 | Special | PDF ↗ |
| K000028 | RENAFLO II HF 2000 HEMOFILTER | Minntech Corp. | 2000-04-04 | Traditional | PDF ↗ |
| K994267 | FRESENIUS 2008K | Fresenius Medical Care | 2000-03-16 | Traditional | PDF ↗ |
| K992563 | A-22 HEMODIALYZER | Althin Medical AB | 2000-01-18 | Traditional | PDF ↗ |
| K992564 | AF-180 HEMODIALYZER | Althin Medical AB | 2000-01-18 | Traditional | PDF ↗ |
| K992566 | AF-150 HEMODIALYZER | Althin Medical AB | 2000-01-18 | Traditional | PDF ↗ |
| K992573 | AF-220 HEMODIALYZER | Althin Medical AB | 2000-01-18 | Traditional | PDF ↗ |
Product code KDI · Class II · Gastroenterology, Urology. Data: openFDA.