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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 / K243815

510(k) cleared

SoClean 3+

Soclean, Inc. · Oct 10, 2025 · K243815

FDA cleared the SoClean 3+ from Soclean, Inc. on Oct 10, 2025 under K243815, a traditional 510(k). The device falls under product code QXQ, Respiratory Accessory Microbial Reduction Device., regulated at 21 CFR 880.6993 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Dec 11, 2024. The decision came 303 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 Soclean, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243815?

K243815 is the FDA 510(k) for SoClean 3+, submitted by Soclean, Inc.. FDA's decision date was Oct 10, 2025, under product code QXQ (Respiratory Accessory Microbial Reduction Device.).

Who makes the SoClean 3+?

Soclean, Inc., based in Peterborough, NH, is the applicant of record for K243815.

How long did the K243815 review take?

FDA received the submission on Dec 11, 2024 and issued its decision on Oct 10, 2025, 303 days later.

← All decisions in October 2025