Not Cleared Direct

DEN210037 - SoClean 3+ Bacterial Reduction Device (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210037 · Soclean, Inc. · General Hospital
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Aug 2024
Decision
1062d
Days
Class 2
Risk

DEN210037 is an FDA 510(k) submission (not cleared) for the SoClean 3+ Bacterial Reduction Device. Classified as Respiratory Accessory Microbial Reduction Device. (product code QXQ), Class II - Special Controls.

Submitted by Soclean, Inc. (Peterborough, US). The FDA issued a Not Cleared (DENG) decision on August 12, 2024 after a review of 1062 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 1062 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Soclean, Inc. devices

Submission Details

510(k) Number DEN210037 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 15, 2021
Decision Date August 12, 2024
Days to Decision 1062 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
934d slower than avg
Panel avg: 128d · This submission: 1062d
Pathway characteristics

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.