SoClean 3+: The First & Only FDA-Cleared Device of Its Kind*
Proven by Science. Backed by Regulatory Standard.
SoClean pioneered the technology that resulted in the establishment of a new FDA device classification. Backed by years of rigorous testing millions invested, and more than 100 patents, SoClean 3+ is the only FDA-cleared device for home-use CPAP hose and mask** care.
WHAT FDA CLEARANCE ACTUALLY MEANS
Clearance Is a Determination.
Not a Label.
“FDA-Cleared” represents a rigorous review process — not a self-certification or unverified marketing claim. It means the FDA evaluated our performance data, safety information, and intended use before granting clearance, providing independent regulatory oversight that goes well beyond self-certification1.
THE DE NOVO PATHWAY
When There Is No Category,
You Have to Build One.
The FDA’s De Novo pathway is reserved for technologies so new that no regulatory framework exists for them. Before SoClean 3+, there was no classification for devices that reduce bacteria on CPAP hoses and masks**. SoClean’s successful De Novo request resulted in the establishment of the FDA classification: Respiratory Accessory Microbial Reduction Devices2.
Other products intended to reduce bacteria on CPAP hoses and masks** would fall within this same FDA classification.
FDA CLASS II MEDICAL DEVICE
Inside Class II: Special Controls,
Ongoing Compliance.
Following De Novo review, SoClean 3+ was classified as a Class II medical device3 — a higher tier of oversight than general consumer products. This means special controls guiding safety and performance apply not just at clearance, but continuously.
YEARS IN THE MAKING
This Is What Proof
Actually Costs.
SoClean’s clearance is the result of 4+ years of dedicated and sustained R&D, tens of millions of dollars invested in independent validation and continuous alignment with FDA review standards.
Testing was conducted across multiple bacterial strains across specific CPAP hoses and masks**. Bacterial reduction performance using the SoClean 3+ is documented, repeated and measurable.1
INTELLECTUAL PROPERTY
A New Technology, Built to Last.
Ozone Stream Technology
SoClean’s core technology is a self-recycling & naturally occurring method of bacterial reduction.
Embedded Software Intelligence
Custom software managing dosing, timing, and environmental sensing — supported by validation testing submitted as part of the FDA De Novo review.
Multi-Layer Security Architecture
Authentication chips designed to help prevent counterfeit components and protect device integrity throughout its lifecycle.
Integrated Sensor Monitoring
Advanced sensors designed to verify system operation consistent with validated performance requirements & bacterial reduction.
Continued Innovation
An active patent portfolio reflects ongoing investment in product development and innovation.
Proprietary System Design
Years of engineering refinement, protected by patents that prevent replication of the core device architecture.
THE POSITION IS CLEAR
First. Only. Proven.
SoClean 3+ is the first and only FDA-cleared device for CPAP hoses and masks** in the Respiratory Accessory Microbial Reduction Device category. Not just the best-known, or most-marketed, but the first device that has undergone FDA review of independently conducted performance testing, received De Novo clearance, and been granted marketing authorization.
READY TO UPGRADE?
The Category Has Been Established. Only One Device is Cleared.
FSA/HSA eligible. FDA-cleared. Patent-protected. Backed by tens of millions of dollars in lab testing and validation. SoClean 3+ is the first & only FDA-Cleared device for 99.9% bacterial reduction in CPAP hoses and masks**.
Explore SoClean 3+
