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 / July 2026 / K251576

510(k) cleared

Total Flow Medical Femoral Arterial (TFA) cannula

Total Flow Medical Limited · Jul 23, 2026 · K251576

FDA cleared the Total Flow Medical Femoral Arterial (TFA) cannula from Total Flow Medical Limited on Jul 23, 2026 under K251576, a traditional 510(k). The review panel was Cardiovascular.

FDA logged the submission as received on May 22, 2025. The decision came 427 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 Total Flow Medical Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251576?

K251576 is the FDA 510(k) for Total Flow Medical Femoral Arterial (TFA) cannula, submitted by Total Flow Medical Limited. FDA's decision date was Jul 23, 2026, under product code SFF.

Who makes the Total Flow Medical Femoral Arterial (TFA) cannula?

Total Flow Medical Limited, based in Vancouver, is the applicant of record for K251576.

How long did the K251576 review take?

FDA received the submission on May 22, 2025 and issued its decision on Jul 23, 2026, 427 days later.

← All decisions in July 2026