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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 / K261950

510(k) cleared

Health Line Tearaway Introducer

Health Line International Corporation · Jun 22, 2026 · K261950

FDA cleared the Health Line Tearaway Introducer from Health Line International Corporation on Jun 22, 2026 under K261950, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 10, 2026. The decision came 12 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Health Line International Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261950?

K261950 is the FDA 510(k) for Health Line Tearaway Introducer, submitted by Health Line International Corporation. FDA's decision date was Jun 22, 2026, under product code DYB (Introducer, Catheter).

Who makes the Health Line Tearaway Introducer?

Health Line International Corporation, based in Salt Lake City, UT, is the applicant of record for K261950.

How long did the K261950 review take?

FDA received the submission on Jun 10, 2026 and issued its decision on Jun 22, 2026, 12 days later.

← All decisions in June 2026