KOC

Accessories, Blood Circuit, Hemodialysis

Product code
KOC
Device name
Accessories, Blood Circuit, Hemodialysis
Device class
Class 2
21 CFR
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Life-sustaining / life-supporting
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
182 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-05-15.

NumberDecision dateApplicantDevice nameSummary
K2424792025-05-15NIKKISO CO., LTD.BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archl…PDF
K2421762025-05-15NIKKISO CO., LTD.BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archl…PDF

2 summaries are archived here for direct download.

Official FDA classification page: KOC
Classification and pathway per current FDA publications. Data from openFDA (CC0).