About This 510(k) Submission
K242479 is an FDA 510(k) clearance for the 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, a Accessories, Blood Circuit, Hemodialysis (Class II — Special Controls, product code KOC), submitted by NIKKISO CO., LTD. (Shibuya-Ku, JP). The FDA issued a Cleared decision on May 15, 2025, 267 days after receiving the submission on August 21, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.