Panels › Gastroenterology, Urology › Product code KOC · Class 2
Accessories, Blood Circuit, Hemodialysis
Regulation 876.5820
0510(k)s in 12 months (182 all time)
4recalls in 12 months (17 all time)
16recalls that name a 510(k)
Top companies in KOC
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2025 | K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CD NIKKISO CO., LTD., JP | KOC |
| May 15, 2025 | K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL NIKKISO CO., LTD., JP | KOC |
| Jul 28, 2023 | K231589 | Blood Tubing Lines for Hemodialysis AV06C-E NIKKISO CO., LTD., JP | KOC |
| Jun 16, 2023 | K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series NIKKISO CO., LTD., JP | KOC |
| Sep 18, 2020 | K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet Fresenius Medical Care Renal Therapies Group, LLC | KOC |
| Dec 14, 2017 | K172238 | CAREline Airless Hemodialysis Blood Tubing Sets Fresenius Medical Care Renal Therapies Group, LLC | KOC |
| Apr 15, 2016 | K160749 | CRIT-LINE III Blood Chamber II Fresenius Medical Care Renal Therapies Group, LLC | KOC |
| Nov 5, 2015 | K152953 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER Fresenius Medical Care North America | KOC |
| Apr 1, 2015 | K141997 | CRIT-LINE IV SYSTEM Fresenius Medical Care | KOC |
| Aug 14, 2014 | K141281 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER Fresenius Medical Care Renal Therapies Group, LLC | KOC |
| Nov 9, 2012 | K121599 | CRIT-LINE CLIP (CLIC) Fresenius Medical Care-North America | KOC |
| Mar 30, 2009 | K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P NIKKISO CO., LTD., JP | KOC |
| Mar 12, 2009 | K081740 | HEMOBAND, MODELS HB-NS AND HB-NSXL Innovations For Access, Inc. | KOC |
| Dec 19, 2008 | K082758 | PRISMAFLO II Stihler Electronic GmbH | KOC |
| Jul 7, 2008 | K081043 | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT Nxstage Medical, Inc. | KOC |
| Oct 18, 2007 | K071909 | PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R Barkey GmbH & Co. KG, DE | KOC |
| Jul 11, 2003 | K030456 | VASC-ALERT Vasc-Alert, LLC | KOC |
| Oct 30, 2002 | K022536 | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR Fresenius Medical Care | KOC |
| Jul 24, 2002 | K020103 | PRISMAFLO Stihler Electronic GmbH | KOC |
| May 16, 2001 | K003712 | MODIFICATION TO MALE TO MALE LUER ADAPTER Molded Products, Inc. | KOC |
| Apr 27, 2001 | K010268 | FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 Fresenius Medical Care North America | KOC |
| Nov 22, 2000 | K002816 | TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV Transonic Systems, Inc. | KOC |
| Oct 25, 2000 | K002372 | ACCESS ALERT GAUGE Medisystems Corp. | KOC |
| Mar 20, 2000 | K994306 | REVERSO Medisystems Corp. | KOC |
| Jan 8, 1999 | K983707 | JMS DIALYZER PRIMING SET Jms Co., Ltd., JP | KOC |
| Nov 26, 1997 | K972206 | NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS Nipro Medical Corp. | KOC |
| Aug 18, 1997 | K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS Medisystems Corp. | KOC |
| Mar 4, 1997 | K954676 | NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS Nissho Corp. | KOC |
| Jan 30, 1997 | K964041 | CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS Robert R. Stevens | KOC |
| Feb 16, 1996 | K955277 | ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS Baxter Healthcare Corp | KOC |
| Jan 11, 1996 | K952572 | DIALYSIS ADMINISTRATION KITS B.Braun Medical, Inc. | KOC |
| Apr 5, 1995 | K950282 | KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA KARL STORZ Endoscopy-America, Inc. | KOC |
| Mar 13, 1995 | K941851 | DUAL LUMEN CATHETER (DLC) TRAY Neostar Medical Technologies, Inc. | KOC |
| Feb 16, 1995 | K941543 | DIAL MEDICAL KIT Regulatory & Marketing Services, Inc. | KOC |
| Jan 30, 1995 | K941803 | PRISM MEDICAL CUSTOM DIALYSIS KIT Medical Device Support Services | KOC |
| Jan 19, 1995 | K935958 | CRIT-LINE BLOOD CHAMBER WITH E-BEAM In-Line Diagnostics Corp. | KOC |
| Oct 7, 1994 | K926374 | SILICONE CATHETER REPAIR KITS Akcess Medical Products, Inc. | KOC |
| Sep 30, 1994 | K925522 | CENTRYSYSTEM 3 WITH CHARTS/BP OPTION C.G.H. Medical, Inc. | KOC |
| Mar 30, 1994 | K925654 | CD HOME DIALYSERVICE HEMODIALYSIS TRAY Cd Medical, Inc. | KOC |
| Mar 15, 1994 | K924436 | BARD UROTRACK II MONITORING C.R. Bard, Inc. | KOC |
| Jun 9, 1993 | K911230 | RS-1000 Cp Medical | KOC |
| Jan 28, 1993 | K920671 | DIGI -FLOW D and D Technology, Inc. | KOC |
| Jul 27, 1992 | K920614 | HEMO-BAND Innovations IN Access, Inc. | KOC |
| Mar 31, 1992 | K912374 | BARD(R) UROTACK(R) 210 MONITORING SYSTEM C.R. Bard, Inc. | KOC |
| Mar 30, 1992 | K913361 | DRAIN/PRIMING/RECIRCULATION BAG Haemotronic, Inc. | KOC |
| Oct 30, 1991 | K911315 | EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT Baxter Healthcare Corp | KOC |
| Sep 27, 1991 | K913483 | MINNILERT(R) PRESSURE MONITOR Minntech Corp. | KOC |
| May 28, 1991 | K911106 | MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG Baxter Healthcare Corp | KOC |
| Apr 29, 1991 | K910641 | INTRODUCER NEEDLES Akcess Medical Products, Inc. | KOC |
| Apr 16, 1991 | K910321 | Y ADAPTOR Akcess Medical Products, Inc. | KOC |
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