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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 / June 2026 / K260916

510(k) cleared

FLEXI-PORT Power Injectable Implantable Port

Portal Access, Inc. · Jun 17, 2026 · K260916

FDA cleared the FLEXI-PORT Power Injectable Implantable Port from Portal Access, Inc. on Jun 17, 2026 under K260916, a traditional 510(k). The device falls under product code LJT, Port & Catheter, Implanted, Subcutaneous, Intravascular, regulated at 21 CFR 880.5965 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 19, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Portal Access, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260916?

K260916 is the FDA 510(k) for FLEXI-PORT Power Injectable Implantable Port, submitted by Portal Access, Inc.. FDA's decision date was Jun 17, 2026, under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular).

Who makes the FLEXI-PORT Power Injectable Implantable Port?

Portal Access, Inc., based in Miami Beach, FL, is the applicant of record for K260916.

How long did the K260916 review take?

FDA received the submission on Mar 19, 2026 and issued its decision on Jun 17, 2026, 90 days later.

← All decisions in June 2026