WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K252759

510(k) cleared

revyve® Antimicrobial Skin and Wound Cleanser

Kane Biotech, Inc. · Jan 8, 2026 · K252759

FDA cleared the revyve® Antimicrobial Skin and Wound Cleanser from Kane Biotech, Inc. on Jan 8, 2026 under K252759, a traditional 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 Aug 29, 2025. The decision came 132 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 Kane Biotech, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252759?

K252759 is the FDA 510(k) for revyve® Antimicrobial Skin and Wound Cleanser, submitted by Kane Biotech, Inc.. FDA's decision date was Jan 8, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the revyve® Antimicrobial Skin and Wound Cleanser?

Kane Biotech, Inc., based in Winnipeg, is the applicant of record for K252759.

How long did the K252759 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Jan 8, 2026, 132 days later.

← All decisions in January 2026