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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 / April 2026 / K254046

510(k) cleared

BosCATH Support Catheter

Sonorous NV, Inc. · Apr 21, 2026 · K254046

FDA cleared the BosCATH Support Catheter from Sonorous NV, Inc. on Apr 21, 2026 under K254046, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 17, 2025. The decision came 125 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 Sonorous NV, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254046?

K254046 is the FDA 510(k) for BosCATH Support Catheter, submitted by Sonorous NV, Inc.. FDA's decision date was Apr 21, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the BosCATH Support Catheter?

Sonorous NV, Inc., based in Lake Forest, CA, is the applicant of record for K254046.

How long did the K254046 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Apr 21, 2026, 125 days later.

← All decisions in April 2026