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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 / October 2025 / K250115

510(k) cleared

Hemastyl() Wound Dressing

Rapid Nexus Nanotech Wound Solutions, Inc. · Oct 14, 2025 · K250115

FDA cleared the Hemastyl() Wound Dressing from Rapid Nexus Nanotech Wound Solutions, Inc. on Oct 14, 2025 under K250115, 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 Jan 16, 2025. The decision came 271 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 Rapid Nexus Nanotech Wound Solutions, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250115?

K250115 is the FDA 510(k) for Hemastyl() Wound Dressing, submitted by Rapid Nexus Nanotech Wound Solutions, Inc.. FDA's decision date was Oct 14, 2025, under product code FRO (Dressing, Wound, Drug).

Who makes the Hemastyl() Wound Dressing?

Rapid Nexus Nanotech Wound Solutions, Inc., based in Brea, CA, is the applicant of record for K250115.

How long did the K250115 review take?

FDA received the submission on Jan 16, 2025 and issued its decision on Oct 14, 2025, 271 days later.

← All decisions in October 2025