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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 / June 2026 / K261638

510(k) cleared

Bonvadis®

Oneness Biotech Co., Ltd. · Jun 17, 2026 · K261638

FDA cleared the Bonvadis® from Oneness Biotech Co., Ltd. on Jun 17, 2026 under K261638, a special 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on May 18, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Oneness Biotech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261638?

K261638 is the FDA 510(k) for Bonvadis®, submitted by Oneness Biotech Co., Ltd.. FDA's decision date was Jun 17, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the Bonvadis®?

Oneness Biotech Co., Ltd., based in Taipei, is the applicant of record for K261638.

How long did the K261638 review take?

FDA received the submission on May 18, 2026 and issued its decision on Jun 17, 2026, 30 days later.

← All decisions in June 2026