FDA Product Code
FDA Product Code KOC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 182 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | NIKKISO CO., LTD. | 2025-05-15 | Traditional | PDF ↗ |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | NIKKISO CO., LTD. | 2025-05-15 | Traditional | PDF ↗ |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | NIKKISO CO., LTD. | 2023-07-28 | Traditional | PDF ↗ |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | NIKKISO CO., LTD. | 2023-06-16 | Traditional | PDF ↗ |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-18 | Traditional | PDF ↗ |
| K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | 2017-12-14 | Traditional | PDF ↗ |
| K160749 | CRIT-LINE III Blood Chamber II | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-15 | Special | PDF ↗ |
| K152953 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care North America | 2015-11-05 | Special | PDF ↗ |
| K141997 | CRIT-LINE IV SYSTEM | Fresenius Medical Care | 2015-04-01 | Traditional | PDF ↗ |
| K141281 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care Renal Therapies Group, LLC | 2014-08-14 | Traditional | PDF ↗ |
| K121599 | CRIT-LINE CLIP (CLIC) | Fresenius Medical Care-North America | 2012-11-09 | Traditional | PDF ↗ |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P | NIKKISO CO., LTD. | 2009-03-30 | Traditional | PDF ↗ |
| K081740 | HEMOBAND, MODELS HB-NS AND HB-NSXL | Innovations For Access, Inc. | 2009-03-12 | Traditional | PDF ↗ |
| K082758 | PRISMAFLO II | Stihler Electronic GmbH | 2008-12-19 | Special | PDF ↗ |
| K081043 | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | Nxstage Medical, Inc. | 2008-07-07 | Traditional | PDF ↗ |
| K071909 | PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R | Barkey GmbH & Co. KG | 2007-10-18 | Abbreviated | PDF ↗ |
| K030456 | VASC-ALERT | Vasc-Alert, LLC | 2003-07-11 | Traditional | PDF ↗ |
| K022536 | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR | Fresenius Medical Care | 2002-10-30 | Traditional | PDF ↗ |
| K020103 | PRISMAFLO | Stihler Electronic GmbH | 2002-07-24 | Abbreviated | PDF ↗ |
| K003712 | MODIFICATION TO MALE TO MALE LUER ADAPTER | Molded Products, Inc. | 2001-05-16 | Traditional | PDF ↗ |
| K010268 | FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 | Fresenius Medical Care North America | 2001-04-27 | Traditional | PDF ↗ |
| K002816 | TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV | Transonic Systems, Inc. | 2000-11-22 | Traditional | PDF ↗ |
| K002372 | ACCESS ALERT GAUGE | Medisystems Corp. | 2000-10-25 | Traditional | PDF ↗ |
| K994306 | REVERSO | Medisystems Corp. | 2000-03-20 | Traditional | PDF ↗ |
| K983707 | JMS DIALYZER PRIMING SET | Jms Co., Ltd. | 1999-01-08 | Traditional | PDF ↗ |
| K972206 | NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS | Nipro Medical Corp. | 1997-11-26 | Traditional | PDF ↗ |
| K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS | Medisystems Corp. | 1997-08-18 | Traditional | PDF ↗ |
| K954676 | NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS | Nissho Corp. | 1997-03-04 | Traditional | PDF ↗ |
| K964041 | CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS | Robert R. Stevens | 1997-01-30 | Traditional | PDF ↗ |
| K955277 | ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS | Baxter Healthcare Corp | 1996-02-16 | Traditional | PDF ↗ |
| K952572 | DIALYSIS ADMINISTRATION KITS | B.Braun Medical, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K950282 | KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA | KARL STORZ Endoscopy-America, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K941851 | DUAL LUMEN CATHETER (DLC) TRAY | Neostar Medical Technologies, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K941543 | DIAL MEDICAL KIT | Regulatory & Marketing Services, Inc. | 1995-02-16 | Traditional | PDF ↗ |
| K941803 | PRISM MEDICAL CUSTOM DIALYSIS KIT | Medical Device Support Services | 1995-01-30 | Traditional | PDF ↗ |
| K935958 | CRIT-LINE BLOOD CHAMBER WITH E-BEAM | In-Line Diagnostics Corp. | 1995-01-19 | Traditional | PDF ↗ |
| K926374 | SILICONE CATHETER REPAIR KITS | Akcess Medical Products, Inc. | 1994-10-07 | Traditional | PDF ↗ |
| K925522 | CENTRYSYSTEM 3 WITH CHARTS/BP OPTION | C.G.H. Medical, Inc. | 1994-09-30 | Traditional | PDF ↗ |
| K925654 | CD HOME DIALYSERVICE HEMODIALYSIS TRAY | Cd Medical, Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K924436 | BARD UROTRACK II MONITORING | C.R. Bard, Inc. | 1994-03-15 | Traditional | PDF ↗ |
| K911230 | RS-1000 | Cp Medical | 1993-06-09 | Traditional | PDF ↗ |
| K920671 | DIGI -FLOW | D and D Technology, Inc. | 1993-01-28 | Traditional | PDF ↗ |
| K920614 | HEMO-BAND | Innovations IN Access, Inc. | 1992-07-27 | Traditional | PDF ↗ |
| K912374 | BARD(R) UROTACK(R) 210 MONITORING SYSTEM | C.R. Bard, Inc. | 1992-03-31 | Traditional | PDF ↗ |
| K913361 | DRAIN/PRIMING/RECIRCULATION BAG | Haemotronic, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K911315 | EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT | Baxter Healthcare Corp | 1991-10-30 | Traditional | PDF ↗ |
| K913483 | MINNILERT(R) PRESSURE MONITOR | Minntech Corp. | 1991-09-27 | Traditional | PDF ↗ |
| K911106 | MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG | Baxter Healthcare Corp | 1991-05-28 | Traditional | PDF ↗ |
| K910641 | INTRODUCER NEEDLES | Akcess Medical Products, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K910321 | Y ADAPTOR | Akcess Medical Products, Inc. | 1991-04-16 | Traditional | PDF ↗ |
| K902588 | BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD | Gambro-Hospal, Inc. | 1991-03-07 | Traditional | PDF ↗ |
| K900306 | HEMODIALYSIS BLOOD LINES | Gainor Medical Europe, Ltd. | 1990-04-20 | Traditional | PDF ↗ |
| K895244 | MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD. | National Medical Care, Medical Products Div., Inc. | 1990-02-12 | Traditional | PDF ↗ |
| K895882 | JMS DIALYZER PRIMING SET | Jms Co., Ltd. | 1990-02-09 | Traditional | PDF ↗ |
| K896006 | DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 | Baxter Healthcare Corp | 1989-12-27 | Traditional | PDF ↗ |
| K894637 | NATIONAL MEDICAL CARE VENOUS LINE 03-9548 | National Medical Care, Medical Products Div., Inc. | 1989-09-22 | Traditional | PDF ↗ |
| K853555 | FAST FORMALERT | Organon Teknika Corp. | 1986-06-26 | Traditional | PDF ↗ |
| K852135 | BSM 21 BLOOD SAFETY MODULE | Hospal Medical Corp. | 1985-06-12 | Traditional | PDF ↗ |
| K852134 | BSM 22 BLOOD SAFETY MODULE | Hospal Medical Corp. | 1985-06-12 | Traditional | PDF ↗ |
| K844504 | SARTORIUS MINISART SM 16596HY | Sartorius Filters, Inc. | 1985-01-18 | Traditional | PDF ↗ |
| K844185 | MODIFIED C-DAK | Cd Medical, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K843531 | ASN MONITOR SINGLE NEEDLE MONITOR | Organon Teknika Corp. | 1984-11-16 | Traditional | PDF ↗ |
| K843632 | HOLLOW FIBER DIALYZER | Travenol Laboratories, S.A. | 1984-10-18 | Traditional | PDF ↗ |
| K840937 | CAPILLARY FLOW DIALYZERS | Travenol Laboratories, S.A. | 1984-09-12 | Traditional | PDF ↗ |
| K840845 | HOLLOW FIBER DIALYZERS | Travenol Laboratories, S.A. | 1984-08-16 | Traditional | PDF ↗ |
| K842436 | ERIKA NEGATIVE PRESS. ARTERIAL BLOOD | Erika, Inc. | 1984-07-13 | Traditional | PDF ↗ |
| K831173 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER | Erika, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K831174 | FILTRYZER HOLLOW FIBER ARTIFICIAL KID- | Erika, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K831176 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY | Erika, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K831175 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY | Erika, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K840859 | MAKS CENTRAL DELIVERY SYS-11-200 ETC | Erika, Inc. | 1984-05-22 | Traditional | PDF ↗ |
| K840654 | DIALYSIS ADMIN. SET - I.V. | Cp Medical | 1984-05-02 | Traditional | PDF ↗ |
| K841124 | DIALYSIS TRAY | Medcare Products | 1984-04-20 | Traditional | PDF ↗ |
| K840062 | BSM 2000 DIALYSIS MACHINE | Organon Teknika Corp. | 1984-03-22 | Traditional | PDF ↗ |
| K834596 | BLOOD TUBING | Renal Systems, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K840057 | EXP* 500 PARALLEL PLATE DIALYZER | Extracorporeal Medical Specialities, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K840146 | EXP* 700 PARALLEL PLATE DIALYZER | Extracorporeal Medical Specialities, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833906 | NEGATIVE PRESSURE VENOUS BLOOD LINE | Erika, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K833896 | BICARBOLYTE HEMO-DIAL | Edlaw Pharmaceuticals, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K833905 | NEGATIVE PRESSURE ARTERIAL BLOOD | Erika, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K833308 | DUAL LUMEN NEEDLE | Quinton, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K833252 | ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF | Erika, Inc. | 1983-12-14 | Traditional | PDF ↗ |
| K833503 | CLIRANS MODEL TAF 15 HOLLOW FIBER | Terumo Medical Corp. | 1983-12-08 | Traditional | PDF ↗ |
| K833440 | BLOOD SAFETY MODULE BSM2 | Hospal Medical Corp. | 1983-12-08 | Traditional | PDF ↗ |
| K832925 | MODIFICATION IN MEMBRANE HOUSING CONFI | Ries Biologicals | 1983-11-28 | Traditional | PDF ↗ |
| K833653 | D-LYTE | Dialysis Products, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K833150 | ASAHI HOLLOW FIBER KIDNEYS, EXCEL | Asahi Medical Co., Ltd. | 1983-11-15 | Traditional | PDF ↗ |
| K832894 | LUNDIA 10-2-L PARALLEL PLATE HEMODIALY | Gambro, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K832623 | TOP DISPOS. INFUSION SET/HEMODIALY | Top Surgical Manufacturers Co. | 1983-10-14 | Traditional | PDF ↗ |
| K832666 | NEPHROSS PRESTO | Organon Teknika Corp. | 1983-10-14 | Traditional | PDF ↗ |
| K832053 | SINGLE PATIENT SYS. II MODEL DM-450 | Extracorporeal Medical Specialities, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K831663 | TISSUE FORCEPS | Medcare Products | 1983-09-26 | Traditional | PDF ↗ |
| K832252 | CLIRANS TAF06 HOLLOW FIBER DIALYZER | Terumo Medical Corp. | 1983-08-26 | Traditional | PDF ↗ |
| K832103 | BLOOD TUBING SET | Lee Medical Intl., Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K831770 | ARTIFICIAL KIDNEY BLOOD CIRCUIT | Eiken Kizai Co., Ltd. | 1983-07-07 | Traditional | PDF ↗ |
| K831409 | HAEMOLYTE SOLUTION | Dialysis Clinic, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K831606 | GF-180-L HOLLOW FIBER HEMODIALYSIS | Gambro, Inc. | 1983-06-24 | Traditional | PDF ↗ |
| K831482 | CLIRANS TAF 120 HOLLOW FIBER DIALYZ. & | Terumo Medical Corp. | 1983-06-03 | Traditional | PDF ↗ |
| K831376 | CDS 2001 ARTIFICIAL KIDNEY | Elmar Medical Systems, Ltd. | 1983-06-03 | Traditional | PDF ↗ |
| K831433 | EXTRASENSR ULTRAFILTRATION MONITOR | Extracorporeal Medical Specialities, Inc. | 1983-06-02 | Traditional | PDF ↗ |
Product code KOC · Class II · Gastroenterology, Urology. Data: openFDA.