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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 / March 2026 / K252023

510(k) cleared

MiraChlor Antimicrobial Wound Solution

Letus Corporation · Mar 25, 2026 · K252023

FDA cleared the MiraChlor Antimicrobial Wound Solution from Letus Corporation on Mar 25, 2026 under K252023, 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 Jun 30, 2025. The decision came 268 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 Letus Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252023?

K252023 is the FDA 510(k) for MiraChlor Antimicrobial Wound Solution, submitted by Letus Corporation. FDA's decision date was Mar 25, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the MiraChlor Antimicrobial Wound Solution?

Letus Corporation, based in Happy Valley, OR, is the applicant of record for K252023.

How long did the K252023 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Mar 25, 2026, 268 days later.

← All decisions in March 2026