Cleared Traditional

K243815 - SoClean 3+ (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243815 · Soclean, Inc. · General Hospital
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Oct 2025
Decision
303d
Days
Class 2
Risk

K243815 is an FDA 510(k) clearance for the SoClean 3+. Classified as Respiratory Accessory Microbial Reduction Device. (product code QXQ), Class II - Special Controls.

Submitted by Soclean, Inc. (Peterborough, US). The FDA issued a Cleared decision on October 10, 2025 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6993 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Soclean, Inc. devices

Submission Details

510(k) Number K243815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2024
Decision Date October 10, 2025
Days to Decision 303 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 128d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QXQ Respiratory Accessory Microbial Reduction Device.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6993
Definition A Respiratory Accessory Microbial Reduction Device Is A Home-use Device Intended To Be Used As An Adjunct For Microbial Reduction Of Compatible Respiratory Accessories,such As Hoses And Masks,after Cleaning. This Device Is Not Intended To Replace The Original Accessory Manufacturer’s Cleaning Instructions.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.