About This 510(k) Submission
K230514 is an FDA 510(k) clearance for the Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series, 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 June 16, 2023, 112 days after receiving the submission on February 24, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.