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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 / February 2026 / K252011

510(k) cleared

CHIKAI Nexus petit

Asahi Intecc Co., Ltd. · Feb 2, 2026 · K252011

FDA cleared the CHIKAI Nexus petit from Asahi Intecc Co., Ltd. on Feb 2, 2026 under K252011, a traditional 510(k). The device falls under product code MOF, Guide, Wire, Catheter, Neurovasculature, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 27, 2025. The decision came 220 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Asahi Intecc Co., Ltd. has one other decision in the tracker over the last 12 months: K254178 (SAYA 86 Radial Access Guide Catheter).

Questions & Answers

What did FDA clear under K252011?

K252011 is the FDA 510(k) for CHIKAI Nexus petit, submitted by Asahi Intecc Co., Ltd.. FDA's decision date was Feb 2, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the CHIKAI Nexus petit?

Asahi Intecc Co., Ltd., based in Seto, is the applicant of record for K252011.

How long did the K252011 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Feb 2, 2026, 220 days later.

← All decisions in February 2026

Sources