Respify is not FDA approved, cleared, or authorized. The FDA has stated clearly that no devices using ozone gas or UV light to clean, disinfect, or sanitize CPAP machines have been approved or cleared for market. This applies to Respify and every other ozone-based CPAP cleaner currently sold.
What the FDA Has Actually Said
The FDA’s position is unambiguous: “There are currently no FDA cleared or approved devices for cleaning, disinfecting, or sanitizing CPAP machines.” The agency has not evaluated the safety or effectiveness of any device claiming to clean CPAP equipment, and it has not received performance data from manufacturers demonstrating that ozone gas or UV light can effectively clean the inside surfaces of CPAP hoses or that these methods don’t damage CPAP equipment.
Respify does appear in the FDA’s MAUDE database, which tracks adverse event reports for medical devices. A product problem report for the “Respify Cleaner and Sanitizer” (model RES2019) was received by the FDA in March 2024. Being listed in this database is not a form of approval. It means the opposite: someone reported a problem with the device to the FDA.
Why Ozone CPAP Cleaners Raise Safety Concerns
Respify and similar devices use ozone gas (sometimes marketed as “activated oxygen”) to kill bacteria inside CPAP tubing, masks, and reservoirs. The core problem is that ozone needs to reach concentrations above what’s safe for humans in order to effectively destroy bacteria. FDA testing found that ozone-based CPAP cleaners generated ambient ozone levels exceeding safe exposure limits, and that ozone remained at high levels inside CPAP equipment even after users waited the full time recommended by manufacturers before using their machines.
The FDA has received reports of people experiencing unexpected asthma attacks, headaches, and breathlessness after using ozone-based devices to clean their CPAP accessories. People with underlying lung conditions like asthma, COPD, or emphysema are particularly sensitive to ozone exposure. Beyond health effects on users, both ozone gas and UV light can physically degrade CPAP components like hoses and masks over time, potentially shortening the life of equipment that’s often expensive to replace.
How CPAP Manufacturers Say to Clean Your Equipment
Most CPAP manufacturers recommend simple cleaning with warm water and mild soap. Some explicitly warn against using ozone or UV light devices on their equipment. Following the manufacturer’s cleaning instructions is the most straightforward approach, and it’s what the FDA recommends. Typical guidance involves washing the mask cushion and water chamber daily, cleaning the tubing weekly, and replacing filters on the schedule specified for your machine.
The appeal of devices like Respify is obvious: nobody wants to hand-wash CPAP parts every day. But the convenience comes with real tradeoffs. You’re breathing through equipment that may retain unsafe ozone levels for hours after cleaning, using a device that no regulatory body has verified actually works, and potentially degrading the very equipment you’re trying to maintain.
What About Other CPAP Cleaners?
The FDA’s position covers the entire category, not just Respify. SoClean, one of the best-known ozone CPAP cleaners, was subject to a voluntary recall and an FDA safety communication. No competitor in this space has achieved FDA clearance or approval either. If you see any CPAP cleaner marketed as “FDA registered,” that’s a different (and much lower) bar than FDA approved. Registration simply means a company has listed itself with the FDA as a device manufacturer. It does not mean the FDA has reviewed or endorsed the product.
The distinction matters because marketing language around these products can be deliberately confusing. “FDA registered facility” and “laboratory tested” are phrases designed to sound like regulatory approval without actually claiming it. If a device were genuinely FDA cleared, the company would say so plainly, because that clearance would be its strongest selling point.