Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series— 510(k) K230514

Clearance details

Applicant

NIKKISO CO., LTD.

Product code

Code KOC

Device class

Class 2

Regulation

21 CFR 876.5820

Advisory panel

Gastroenterology, Urology

Date received

2023-02-24

Decision date

2023-06-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shibuya-Ku, JP

• K242176 — 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)2025-05-15
• K242479 — 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-PU2025-05-15
• K231589 — Blood Tubing Lines for Hemodialysis AV06C-E2023-07-28
• K201207 — 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 Line2020-09-18
• K172238 — CAREline Airless Hemodialysis Blood Tubing Sets2017-12-14

• K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)2025-05-15
• K152938 — DBB-06 Hemodialysis Delivery System2016-03-18
• K091978 — DBB-06 HEMODIALYSIS DELIVERY SYSTEM2010-03-25
• K082719 — NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P2009-03-30
• K061519 — MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM2007-09-28

Death

4

Total

4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →