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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 / January 2026 / K250890

510(k) cleared

SBC1 Cream

Sioxmed, LLC · Jan 12, 2026 · K250890

FDA cleared the SBC1 Cream from Sioxmed, LLC on Jan 12, 2026 under K250890, 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 Mar 25, 2025. The decision came 293 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 Sioxmed, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250890?

K250890 is the FDA 510(k) for SBC1 Cream, submitted by Sioxmed, LLC. FDA's decision date was Jan 12, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the SBC1 Cream?

Sioxmed, LLC, based in Winston Salem, NC, is the applicant of record for K250890.

How long did the K250890 review take?

FDA received the submission on Mar 25, 2025 and issued its decision on Jan 12, 2026, 293 days later.

← All decisions in January 2026