Frequently Asked Questions about Molekule’s FDA Medical Device Clearance

 

In April of 2020 Molekule’s Air Pro RX received Class 2 medical device clearance from the FDA. That means Molekule is officially a medical device company.

The FDA has more than one process for ensuring that medical devices are safe for use by the American public because different devices carry different levels of risk. If a tongue depressor doesn’t work right there’s far less risk than if a defibrillator fails, for example. Molekule Air Pro RX was cleared as a Class 2 medical device which means that we demonstrated to the FDA that it is safe, effective, and substantially equivalent to an already marketed medical device.

Molekule Pro Rx, the newest addition to the Molekule family.

The clearance process is extremely rigorous and required data from controlled, scientifically sound experiments. Molekule submitted what is known as a 510(k) premarket submission to the FDA, which is a document showing that our device meets all of the requirements to be cleared as a Class 2 medical device. Since getting clearance Molekule Air Pro RX has been deployed in healthcare settings around the nation.

While Molekule Air Pro RX is cleared as a medical device, our other devices also have PECO technology, which is still very special. As a result of the pandemic the FDA released five criteria for air purifiers to meet in order to show they can reduce the risk of Covid-19 spreading. PECO meets or exceeds all of the criteria, even going an extra order of magnitude in reducing viable airborne virus particles, achieving 99.999% reduction in laboratory testing.

This is not the first or the last step in Molekule’s ongoing mission to keep the air clean for everyone to breathe. Stay tuned to our blog and keep up to date.

Written by