Clearance Summary
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) received FDA 510(k) clearance under submission number K251442, sponsored by Ningbo Tianyi Medical Appliance Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-10-02.
- Submission: K251442
- Applicant / Sponsor: Ningbo Tianyi Medical Appliance Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2025-10-02
Classification & Regulation
This clearance is catalogued under FDA product code FJK and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.