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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 / K251668

510(k) cleared

SurfRider 13 Microcatheter

Kaneka Americas Holding, Inc. · Jan 5, 2026 · K251668

FDA cleared the SurfRider 13 Microcatheter from Kaneka Americas Holding, Inc. on Jan 5, 2026 under K251668, 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 May 30, 2025. The decision came 220 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 Kaneka Americas Holding, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251668?

K251668 is the FDA 510(k) for SurfRider 13 Microcatheter, submitted by Kaneka Americas Holding, Inc.. FDA's decision date was Jan 5, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the SurfRider 13 Microcatheter?

Kaneka Americas Holding, Inc., based in Newark, CA, is the applicant of record for K251668.

How long did the K251668 review take?

FDA received the submission on May 30, 2025 and issued its decision on Jan 5, 2026, 220 days later.

← All decisions in January 2026