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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K251442

510(k) cleared

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

Ningbo Tianyi Medical Appliance Co., Ltd. · Oct 2, 2025 · K251442

FDA cleared the TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) from Ningbo Tianyi Medical Appliance Co., Ltd. on Oct 2, 2025 under K251442, a traditional 510(k). The device falls under product code FJK, Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, regulated at 21 CFR 876.5820 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 9, 2025. The decision came 146 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Ningbo Tianyi Medical Appliance Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251442?

K251442 is the FDA 510(k) for TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1), submitted by Ningbo Tianyi Medical Appliance Co., Ltd.. FDA's decision date was Oct 2, 2025, under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve).

Who makes the TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)?

Ningbo Tianyi Medical Appliance Co., Ltd., based in Ningbo, is the applicant of record for K251442.

How long did the K251442 review take?

FDA received the submission on May 9, 2025 and issued its decision on Oct 2, 2025, 146 days later.

← All decisions in October 2025