FDA.reportPublic FDA data

510(k) K230514

Device
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
Applicant
NIKKISO CO., LTD.
510(k) number
K230514
Product code
KOC
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-16
Date received
2023-02-24
Regulation
876.5820
Classification name
Accessories, Blood Circuit, Hemodialysis
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Satoko Hina
Address
20-3, Ebisu 4-Chome Shibuya-Ku JP 150-6022 150-6022

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KOC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242176BLOOD 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
K242479BLOOD 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-PUNIKKISO CO., LTD.2025-05-15
K231589Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD.2023-07-28
K201207CombiSet 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 LineFresenius Medical Care Renal Therapies Group, LLC2020-09-18
K172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC2017-12-14
K160749CRIT-LINE III Blood Chamber IIFresenius Medical Care Renal Therapies Group, LLC2016-04-15
K152953CRIT-LINE CLIP (CLIC) BLOOD CHAMBERFresenius Medical Care North America2015-11-05
K141997CRIT-LINE IV SYSTEMFresenius Medical Care2015-04-01
K141281CRIT-LINE CLIP (CLIC) BLOOD CHAMBERFresenius Medical Care Renal Therapies Group, LLC2014-08-14
K121599CRIT-LINE CLIP (CLIC)Fresenius Medical Care-North America2012-11-09
K082719NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-PNIKKISO CO., LTD.2009-03-30
K081740HEMOBAND, MODELS HB-NS AND HB-NSXLInnovations For Access, Inc.2009-03-12
K082758PRISMAFLO IIStihler Electronic GmbH2008-12-19
K081043LEAK DETECTION SENSOR AND TRAY ACCESSORY KITNxstage Medical, Inc.2008-07-07
K071909PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4RBarkey GmbH & Co. KG2007-10-18