KOC · Class II · 21 CFR 876.5820

FDA Product Code KOC: Accessories, Blood Circuit, Hemodialysis

Leading manufacturers include Sorensen Research, Erika, Inc. and Extracorporeal Medical Specialities, Inc..

182
Total
182
Cleared
105d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 281d recently vs 104d historically

FDA 510(k) Cleared Accessories, Blood Circuit, Hemodialysis Devices (Product Code KOC)

182 devices
1–24 of 182
Cleared May 15, 2025
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)
K242176
NIKKISO CO., LTD.
Gastroenterology & Urology · 295d
Cleared May 15, 2025
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
K242479
NIKKISO CO., LTD.
Gastroenterology & Urology · 267d
Cleared Jul 28, 2023
Blood Tubing Lines for Hemodialysis AV06C-E
K231589
NIKKISO CO., LTD.
Gastroenterology & Urology · 57d
Cleared Jun 16, 2023
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
K230514
NIKKISO CO., LTD.
Gastroenterology & Urology · 112d
Cleared Sep 18, 2020
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
K201207
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 136d
Cleared Dec 14, 2017
CAREline Airless Hemodialysis Blood Tubing Sets
K172238
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 141d
Cleared Apr 15, 2016
CRIT-LINE III Blood Chamber II
K160749
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 28d
Cleared Nov 05, 2015
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K152953
Fresenius Medical Care North America
Gastroenterology & Urology · 29d
Cleared Apr 01, 2015
CRIT-LINE IV SYSTEM
K141997
Fresenius Medical Care
Gastroenterology & Urology · 252d
Cleared Aug 14, 2014
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K141281
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 90d
Cleared Nov 09, 2012
CRIT-LINE CLIP (CLIC)
K121599
Fresenius Medical Care North America
Gastroenterology & Urology · 161d
Cleared Mar 30, 2009
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P
K082719
NIKKISO CO., LTD.
Gastroenterology & Urology · 194d
Cleared Mar 12, 2009
HEMOBAND, MODELS HB-NS AND HB-NSXL
K081740
Innovations For Access, Inc.
Gastroenterology & Urology · 266d
Cleared Dec 19, 2008
PRISMAFLO II
K082758
Stihler Electronic GmbH
Gastroenterology & Urology · 91d
Cleared Jul 07, 2008
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
K081043
Nxstage Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 18, 2007
PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R
K071909
Barkey GmbH & Co. KG
Gastroenterology & Urology · 99d
Cleared Jul 11, 2003
VASC-ALERT
K030456
Vasc-Alert, LLC
Gastroenterology & Urology · 150d
Cleared Oct 30, 2002
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
K022536
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared Jul 24, 2002
PRISMAFLO
K020103
Stihler Electronic GmbH
Gastroenterology & Urology · 194d
Cleared May 16, 2001
MODIFICATION TO MALE TO MALE LUER ADAPTER
K003712
Molded Products, Inc.
Gastroenterology & Urology · 166d
Cleared Apr 27, 2001
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
K010268
Fresenius Medical Care North America
Gastroenterology & Urology · 88d
Cleared Nov 22, 2000
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
K002816
Transonic Systems, Inc.
Gastroenterology & Urology · 72d
Cleared Oct 25, 2000
ACCESS ALERT GAUGE
K002372
Medisystems Corp.
Gastroenterology & Urology · 82d
Cleared Mar 20, 2000
REVERSO
K994306
Medisystems Corp.
Gastroenterology & Urology · 90d

About Product Code KOC - Regulatory Context

510(k) Submission Activity

182 total 510(k) submissions under product code KOC since 1976, with 182 receiving FDA clearance (average review time: 105 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - KOC Product Code

Recent submissions under KOC have taken an average of 281 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.

KOC devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →