CerroZone receives FDA 510(k) Class II clearance
NOTE: On September 23, 2024, CerroZone™ announced it has branded its technology and product portfolio to reflect its groundbreaking indoor air purification technology. Moving forward, its products will go to market as CereneAir™, a new brand that highlights the organization’s mission to establish a new standard for indoor air. Learn more
CerroZone’s new mobile air purification device has earned 510(k) Class II clearance from the U.S. Food and Drug Administration as a recirculating air cleaner for eliminating airborne viruses and bacteria. The FDA approval was contingent on extensive testing at accredited independent third-party facilities.
The CerroZone mobile unit is designed to purify air in buildings such as schools, retail environments, offices, and other indoor spaces. CerroZone’s indoor system achieved a 99.998 percent reduction of live COVID-19 Delta Variant in a single pass of approximately 1.2 seconds, according to independent testing at MRI Global in Kansas City.
Unlike other solutions, the CerroZone product features patented ozone technology. “This is the first technology to truly harness the disinfecting power of ozone in a way that is safe for consumers and the environment,” said Michael Duggan, President of St. Louis, Mo.-based CerroZone. “It will fundamentally change the industry standard for air purification.”
CerroZone previously announced it had achieved Intertek’s Zero Ozone Certification. Intertek considers emissions of .005 ppm or less to be negligible per UL 2998, the North American industry standard for ozone testing. The CerroZone unit recorded at only .001 ppm.
Among its benefits to the market, the CerroZone™ platform only requires annual preventive maintenance, unlike filtration-based systems that need quarterly replacement of filters and other components.
“Today's news further validates the exceptional quality of our system,” said Marlon Robinson, Director of Operations for CerroZone. “We knew the effectiveness of the CerroZone unit based on our prior testing, including on live COVID-19. To show similar effectiveness on a different strain reinforces that CerroZone is positioned to aid the public in the fight against emerging and future variants.”
Robinson added, “We are now ready to commercialize this amazing technology. We have been methodical in our approach, with successful field trials consistently demonstrating our product’s performance. We look forward to providing the market with an effective, proven solution including an attractive preventive maintenance schedule.”
