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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 / March 2026 / K260502

510(k) cleared

Liv Pre-lubricated Intermittent Catheter

HR Healthcare · Mar 12, 2026 · K260502

FDA cleared the Liv Pre-lubricated Intermittent Catheter from HR Healthcare on Mar 12, 2026 under K260502, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code EZD, Catheter, Straight, regulated at 21 CFR 876.5130 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 13, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

HR Healthcare has 2 other decisions in the tracker over the last 12 months: K251274 (EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits), K253639 (View).

Questions & Answers

What did FDA clear under K260502?

K260502 is the FDA 510(k) for Liv Pre-lubricated Intermittent Catheter, submitted by HR Healthcare. FDA's decision date was Mar 12, 2026, under product code EZD (Catheter, Straight).

Who makes the Liv Pre-lubricated Intermittent Catheter?

HR Healthcare, based in York, PA, is the applicant of record for K260502.

How long did the K260502 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Mar 12, 2026, 27 days later.

← All decisions in March 2026

Sources