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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 / K251866

510(k) cleared

Tegaderm Post-Op Transparent Antimicrobial Dressing

Solventum US, LLC · Oct 10, 2025 · K251866

FDA cleared the Tegaderm Post-Op Transparent Antimicrobial Dressing from Solventum US, LLC on Oct 10, 2025 under K251866, 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 17, 2025. The decision came 115 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 Solventum US, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251866?

K251866 is the FDA 510(k) for Tegaderm Post-Op Transparent Antimicrobial Dressing, submitted by Solventum US, LLC. FDA's decision date was Oct 10, 2025, under product code FRO (Dressing, Wound, Drug).

Who makes the Tegaderm Post-Op Transparent Antimicrobial Dressing?

Solventum US, LLC, based in San Antonio, TX, is the applicant of record for K251866.

How long did the K251866 review take?

FDA received the submission on Jun 17, 2025 and issued its decision on Oct 10, 2025, 115 days later.

← All decisions in October 2025