FDA.reportPublic FDA data

510(k) K242479

Device
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
Applicant
NIKKISO CO., LTD.
510(k) number
K242479
Product code
KOC
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-15
Date received
2024-08-21
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
N

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
K231589Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD.2023-07-28
K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNIKKISO CO., LTD.2023-06-16
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