About This 510(k) Submission
K251442 is an FDA 510(k) clearance for the TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1), a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Ningbo Tianyi Medical Appliance Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on October 2, 2025, 146 days after receiving the submission on May 9, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.