KOC · Class II · 21 CFR 876.5820

FDA Product Code KOC: Accessories, Blood Circuit, Hemodialysis

Leading manufacturers include NIKKISO CO., LTD., Cordis Corp. and Baxter Healthcare Corp.

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 Feb 16, 1996
ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS
K955277
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Apr 05, 1995
KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA
K950282
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 71d
Cleared Mar 15, 1994
BARD UROTRACK II MONITORING
K924436
C.R. Bard, Inc.
Gastroenterology & Urology · 560d
Cleared Mar 31, 1992
BARD(R) UROTACK(R) 210 MONITORING SYSTEM
K912374
C.R. Bard, Inc.
Gastroenterology & Urology · 307d
Cleared Oct 30, 1991
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315
Baxter Healthcare Corp
Gastroenterology & Urology · 218d
Cleared May 28, 1991
MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG
K911106
Baxter Healthcare Corp
Gastroenterology & Urology · 77d
Cleared Dec 27, 1989
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006
Baxter Healthcare Corp
Gastroenterology & Urology · 75d
Cleared Mar 29, 1983
C-DAK ARTIFICIAL KIDNEY
K830729
Cordis Corp.
Gastroenterology & Urology · 21d
Cleared Jul 08, 1980
BIONICS ARTERIAL/VENOUS FISTULA NEEDLE
K801354
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
K801355
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 08, 1980
BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET
K801356
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Aug 30, 1976
BLOOD TUBING SETS
K760042
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology · 76d

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 →