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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 / February 2026 / K260043

510(k) cleared

Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)

Smart Reactors · Feb 23, 2026 · K260043

FDA cleared the Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) from Smart Reactors on Feb 23, 2026 under K260043, a traditional 510(k). The device falls under product code DWF, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, regulated at 21 CFR 870.4210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 7, 2026. The decision came 47 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Smart Reactors in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260043?

K260043 is the FDA 510(k) for Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C), submitted by Smart Reactors. FDA's decision date was Feb 23, 2026, under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

Who makes the Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)?

Smart Reactors, based in Galway, is the applicant of record for K260043.

How long did the K260043 review take?

FDA received the submission on Jan 7, 2026 and issued its decision on Feb 23, 2026, 47 days later.

← All decisions in February 2026