Is SoClean FDA Certified?

Last Updated on November 18, 2021 by

SoClean is not certified by FDA. According to FDA, SoClean and other devices used to clean Continuous Positive Airway Pressure(CPAP) machines produce ozone levels that are risky for humans. A study also found that these ozone levels linger in the CPAP machines longer than they should, making SoClean uncleared and unapproved for use in the USA.

What Is FDA’s Take On SoClean Products?

The Food and Drug Administration ensures products used are safe and human-friendly. They carry out studies on new products in the market, including SoClean. FDA aims to ban the use of products that give out high ozone levels, which cause respiratory diseases and skin cancer. Excess ultraviolet light from lumen cleaners leads to eye damages. Some cleaning products such as SoClean produce these harmful substances. 

Further studies have proved that chemicals used to manufacture SoClean gases release ozone gas harmful to your health and kill bacteria. Ozone levels which can bacteria are considered unsafe for humans. For this reason, FDA advises users to ensure proper cleaning of CPAP. They must also allow fresh air to flow through the machine system to avoid breathing in the ozone gas. When cleaning using UV light, it is important to ensure it is strong enough to sanitize the CPAP System.

The FDA stated that SoClean is used to clean and disinfect CPAP machines and is still unapproved for sale and marketing. Using Soclean exposes you to great risk as it is uncertified and uncleared for use by the US government. More studies are underway, including monitoring to identify possible adverse effects resulting from SoClean producing ozone gas and ultraviolet light. The FDA encourages all individuals using this product to give their experiences and reports on any adverse effects.

What Is The SoClean Cleaner Machine?

A SoClean cleaner is a cleaning equipment used to clean and disinfect CPAP machines. It uses activated oxygen to dry its parts instead of cleaning water. Using this equipment can deteriorate your health since once you use it to clean equipment, you will use it more often, usually daily. It harms your health from the released gases during cleaning, which includes the ozone gas.

 Since the product is compatible with most appliances, many people may prefer to use it. The SoClean cleaner comes with different adapters that you can use on different items for free. It also has a cleaning cycle of two hours. After purchase, the manufacturers offer the user a 30-day risk-free trial, free shipping, and delivery. It comes with a cartridge filter kit that you are required to replace after six months. The cartridge replacement cost is approximately $30 or less, depending on your location, which helps to estimate the delivery fee. 

Activated oxygen used in the SoClean equipment helps to kill and destroy bacteria and germs on surfaces. Most people go for it since it is easy to use. It only requires you to put your machine inside the SoClean cleaner, lock it in, and start automatically sanitizing and cleaning the items. 

What Are The Warning Signs You Should Look Out For When Using SoClean?

SoClean is intended for home use to destroy germs and unwanted bacteria within a household. It is for carrying out thorough disinfection and sanitization of equipment. Below are some of the warning signs provided by the SoClean manufacturers when using it;

1. Keep the equipment away from the reach of children. Chemicals used and those released after passing through activated oxygen can be harmful to anyone’s health. Children may feel tempted to use it as a playing item leading to accidents and complications resulting from ozone gases produced during disinfection and cleaning. 

2. Ensure the SoClean machine completes its cleaning cycle. You can achieve this by setting its starting time all the time before using it. The equipment has AM and PM settings that must be adhered to since failure to put the right settings could lead to the cleaning machine operating under unspecified time. It can over-clean or under-clean a machine. While others have no problem with over cleaning, some materials may react to the activated oxygen letting out harmful gases and other products.

3. Always keep the SoClean equipment away from all water sources such as bathtubs, rain, taps, pools, and sinks. You can clean it by wiping it carefully using a damp cloth instead of submerging it in water. It would be best to avoid any chemical cleaners. Instead, use plain water and a cloth to wipe its surface.

4. If you happen to detect a strong ozone gas odour while using your SoClean equipment, turn it off by disconnecting it from the main power source and inspecting it for any visible physical damages. Some damages that cause ozone leaks are cracks on its enclosure and poor tubing along with its tube connections. Ozone gas is harmful to your health as it causes respiratory diseases and may worsen for people with asthmatic conditions. 

5. Do not use SoClean cleaner equipment in an explosive environment such as near flammable substances like other gas vapours. Oxygen supports combustion, and when applied in high pressure, it causes explosions that are likely to cost people’s lives and property. For this reason, you should avoid placing the equipment near or above ignitable items to prevent such accidents from happening. 

6. Always maintain the SoClean lid tightly closed until the cleaning cycle is complete. It shows a complete cycle by giving a green light illuminate, indicating the end of a cleaning session. 

7. Other warnings include; avoid dismantling the SoClean equipment no matter what the situation. Its component’s wrong combination can cause an explosion or a small but highly dangerous leak. 

8. Avoid removing the equipment’s gasket from its hose with a slot.  

9. Another important warning is to avoid inhaling the activated oxygen from the injection hose of the SoClean cleaner, its injection hose outlet, or even from its back. The gas is not safe for breathing in, especially in large quantities. It may cause respiratory diseases such as difficulty in breathing. 

Which Is Better Between Lumen Cleaner And SoClean?

Lumen is a cleaner, just like the SoClean equipment. It cleans and disinfects CPAP machines using ultraviolet technology, unlike SoClean, which uses activated oxygen. It acts by destroying and killing germs and bacteria on surfaces. The main issue associated with lumen as a CPAP machine cleaner is that it generates a bad odor, creating an uncomfortable environment for other people. It also does not clean the CPAP tubes as it only cleans the exposed surfaces of a machine.

On the other hand, so clean eliminates 99.9% of bacteria and germs from the CPAP machines. It is customizable, which makes it easier and more convenient to use compared to lumen cleaner. It is also compatible with a wide range of equipment. It has a wide enough chamber to fit different CPAP machine types for sanitizing and cleaning. SoClean machine is quite expensive since some of its parts require replacement after every six months. It is also associated with producing ozone gas which is harmful when inhaled. 

Both have similar functionality. Lumens and SoClean are fast cleaners and CPAP machines. They also both emit odor during cleaning. For effectiveness, SoClean is the better cleaner as it penetrates machines’ deeper cores, unlike lumen cleaner, which only kills bacteria and germs off the visible surfaces.

What Is The Difference Between Lumen Cleaner And SoClean?

SoClean and lumen cleaners may function similarly, but they still do have their differences. Their major differences are in their structure, price range, durability, renewability, and working mechanism, among other factors. The table below is a comparison between the two cleaners;

SoCleanLumen cleaner
Renewability They are not only expensive but also require regular replacement of some of their components. Most SoClean machine parts require replacement after every six months making maintenance a little bit more expensive.They are cheaper to buy and require relatively low maintenance costs. Their components are long-lasting, and they are effective as long as the lumen machine is functional.
Cleaning speedIt takes at least 2 hours to complete a cleaning cycle, including disinfecting. It is very efficient since it cleans up the interior most parts of the CPAP machines.It is a fast cleaner as it takes utmost 5 minutes for a complete cleaning cycle. It is not the best alternative if you are looking for efficiency.
Price rangeThey are quite expensive, ranging from $300 to 400$, exclusive of high maintenance expenses due to the regular parts replacement.They are cheaper with their prices ranging from $200 to $300. They require very little maintenance, provided you keep them safe and away from children.


SoClean is not FDA certified as studies indicate that its effects are life-threatening. People still purchase the product despite it not being approved for marketing by the US FDA. Users are only going for them as an alternative to clean their CPAP machines at risk of being exposed to ozone gases that are harmful to their health. Ozone gas causes respiratory diseases and worsens cases of asthmatic conditions, which could be fatal.

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