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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 / April 2026 / K252116

510(k) cleared

Firefighter Pro PTCA Balloon Catheter

Shanghai MicroPort Medical (Group) Co., Ltd. · Apr 7, 2026 · K252116

FDA cleared the Firefighter Pro PTCA Balloon Catheter from Shanghai MicroPort Medical (Group) Co., Ltd. on Apr 7, 2026 under K252116, a traditional 510(k). The device falls under product code LOX, Catheters, Transluminal Coronary Angioplasty, Percutaneous, regulated at 21 CFR 870.5100 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 7, 2025. The decision came 274 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 Shanghai MicroPort Medical (Group) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252116?

K252116 is the FDA 510(k) for Firefighter Pro PTCA Balloon Catheter, submitted by Shanghai MicroPort Medical (Group) Co., Ltd.. FDA's decision date was Apr 7, 2026, under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous).

Who makes the Firefighter Pro PTCA Balloon Catheter?

Shanghai MicroPort Medical (Group) Co., Ltd., based in Shanghai, is the applicant of record for K252116.

How long did the K252116 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Apr 7, 2026, 274 days later.

← All decisions in April 2026