WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / May 2026 / K252423

510(k) cleared

NovaLine Tubing Set for Hemodialysis (BL 124)

Bain Medical Equipment (Guangzhou) Co., Ltd. · May 15, 2026 · K252423

FDA cleared the NovaLine Tubing Set for Hemodialysis (BL 124) from Bain Medical Equipment (Guangzhou) Co., Ltd. on May 15, 2026 under K252423, 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 Aug 1, 2025. The decision came 287 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 Bain Medical Equipment (Guangzhou) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252423?

K252423 is the FDA 510(k) for NovaLine Tubing Set for Hemodialysis (BL 124), submitted by Bain Medical Equipment (Guangzhou) Co., Ltd.. FDA's decision date was May 15, 2026, under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve).

Who makes the NovaLine Tubing Set for Hemodialysis (BL 124)?

Bain Medical Equipment (Guangzhou) Co., Ltd., based in Guangzhou, is the applicant of record for K252423.

How long did the K252423 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on May 15, 2026, 287 days later.

← All decisions in May 2026