Molekule Air Mini & Air Mini+ Receive FDA 510(k) Class II Medical Device Clearance

Clearance marks Molekule's first FDA cleared products for medical use in the home.

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Mar 09, 2021, 03:00 ET

SAN FRANCISCO, March 9, 2021 /PRNewswire/ -- Molekule today announced that the U.S. Food and Drug Administration (FDA) cleared the 510(k) premarket notification for its existing air purifiers, Air Mini and Air Mini+, classifying them as Class II medical devices. Air Mini and Air Mini+ are now cleared for medical use to destroy bacteria and viruses.

"Today's clearance from the FDA is a proud moment for the company and a huge step for the air purification industry as a whole. Air is extremely complex and contains much more than just particulate matter. That's why PECO technology was created," said Jaya Rao, CEO and Co-Founder of Molekule. "The process with the FDA is rigorous and Molekule is pleased that Air Mini and Air Mini+ were able to achieve this milestone. Molekule understands that purchasers need to trust air purifiers, and that's why it tests its air purifiers against some of the world's most stringent standards."

All of Molekule's air purification devices use the company's patented Photo Electrochemical Oxidation (PECO) technology, which captures inorganic particulate matter like dust and dander, and oxidizes, or destroys, organic airborne pollutants, specifically, viruses and bacteria. Importantly, Air Mini and Air Mini+ were demonstrated to FDA to have greater than 5-log, or 99.999% reduction of RNA virus MS2, in just two hours.

This marks a major milestone in the company's history. The 510(k) clearance is one that few air purification companies selling on market today have shown that they are qualified for, and even fewer have successfully deployed products at the scale that Molekule has. Molekule now has three FDA cleared products on the market today. This milestone marks the company's deep commitment to scientific testing and validation of its air purification technology, PECO, as it works to help move the industry forward.

Air Mini and Air Mini+ have been developed as ideal solutions for air purification in smaller spaces in healthcare environments and for medical use in the home. Another Molekule device, Air Pro RX, received FDA 510(k) clearance in April 2020 and is currently in use at medical facilities, including Mercyhealth and Reddy Care Physical Therapy, among others, helping to provide cleaner air in critical medical spaces.

About Molekule

Molekule is on a mission to provide clean indoor air to everyone, everywhere. Based on 25 years of research and development, the company's patented photo electrochemical oxidation (PECO) technology destroys the widest range of pollutants, including VOCs, mold, bacteria, viruses, and allergens, when compared to conventional filters. Molekule's range of air purification solutions have been reviewed and validated by third-party laboratories, as well as continual internal testing, and its medical-grade product has been granted medical device clearance by the FDA. Today, Molekule is available at Best Buy, Apple and on Amazon. It is also sold internationally in India, Japan, South Korea, and Canada. For more information, visit https://molekule.com.

Molekule Media Contact
Stephanie Borman
[email protected]

SOURCE Molekule