The Truth About Air Purifiers as Medical Devices

Discover the truth about air purifiers and their classification as medical devices by the FDA. Learn about the rigorous process companies must go through to meet FDA standards and find out what to look for when choosing an air purifier.

The Truth About Air Purifiers as Medical Devices

As an expert in the field of air purification, I have seen many companies claim that their air purifiers are suitable for medical use. However, the reality is that only a select few have been recognized by the FDA as Class II medical devices. One such device is the Defender air purifier, which has held this classification for over 20 years. In order to be recognized as a medical device by the FDA, a company must go through a rigorous process of research and interaction with the FDA. This ensures that the device meets the necessary standards and regulations set by the FDA.

In the United States, the FDA is responsible for setting these standards for medical devices. According to FDA regulations, air purifiers should be able to capture at least 99.99% of declared particles. This is especially important for people with asthma and allergies, as they require strict criteria to identify excellent air purification products. While common air purifiers can remove PM2.5 particles, medical air purifiers are able to remove even smaller particles, as small as 0.3 microns. When searching for an air purifier, you may come across various terms related to different technologies used in air purification. To help you find the best one for your needs, here's an overview of the different methods used in air purification. It's important to note that the information provided on this website is for general information purposes only and should not be used as a substitute for professional medical advice.

When choosing an air purifier, it's best to focus on factors such as filtration rate, CADR (Clean Air Delivery Rate), and price rather than just looking for ones labeled as "suitable for medical use." At Smart Air, we offer affordable and empirically backed purifiers and masks that are just as effective as those from larger companies. Unfortunately, in the midst of the COVID-19 pandemic, many companies have taken advantage of the situation by marketing their devices as UV air purifiers. However, these claims are often false and misleading. Whether you're looking for an air purifier to protect your home from viruses like COVID-19 or to alleviate allergens and mold, we have a solution for you. It's important to note that if a company's air purifier is not on the FDA's list of recognized medical devices, they may be falsely advertising their product as suitable for medical use. Air purifiers with UV technology gained a lot of attention last year for their ability to reduce biopollutants and deactivate viruses and bacteria. However, in general, we believe that medical air purifiers with HEPA (High-Efficiency Particulate Air) filters are just as effective.

These filters have a 99.97% efficiency rate for particles larger than 0.3 microns in diameter, making them comparable to medical air purifiers.

Eloise Grosshans
Eloise Grosshans

Avid coffee lover. Lifelong music lover. General internet evangelist. Infuriatingly humble music advocate. Professional pop culture expert. Hardcore tea nerd.