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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 / January 2026 / K252297

510(k) cleared

Toro 88 Superbore Catheter

Toro Neurovascular, Inc. · Jan 16, 2026 · K252297

FDA cleared the Toro 88 Superbore Catheter from Toro Neurovascular, Inc. on Jan 16, 2026 under K252297, 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 Jul 23, 2025. The decision came 177 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 Toro Neurovascular, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252297?

K252297 is the FDA 510(k) for Toro 88 Superbore Catheter, submitted by Toro Neurovascular, Inc.. FDA's decision date was Jan 16, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Toro 88 Superbore Catheter?

Toro Neurovascular, Inc., based in Irvine, CA, is the applicant of record for K252297.

How long did the K252297 review take?

FDA received the submission on Jul 23, 2025 and issued its decision on Jan 16, 2026, 177 days later.

← All decisions in January 2026