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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 / May 2026 / K254178

510(k) cleared

SAYA 86 Radial Access Guide Catheter

Asahi Intecc Co., Ltd. · May 11, 2026 · K254178

FDA cleared the SAYA 86 Radial Access Guide Catheter from Asahi Intecc Co., Ltd. on May 11, 2026 under K254178, 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 23, 2025. The decision came 139 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: K252011 (CHIKAI Nexus petit).

Questions & Answers

What did FDA clear under K254178?

K254178 is the FDA 510(k) for SAYA 86 Radial Access Guide Catheter, submitted by Asahi Intecc Co., Ltd.. FDA's decision date was May 11, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the SAYA 86 Radial Access Guide Catheter?

Asahi Intecc Co., Ltd., based in Seto, is the applicant of record for K254178.

How long did the K254178 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on May 11, 2026, 139 days later.

← All decisions in May 2026

Sources