FDA Approves Bluezone For Medical Device Clearance

Bluezone and Middleby are proud to share the Bluezone 450 air purifier has been approved by the Food and Drug Administration (FDA) as a medical device. The model is now an official medical device for antiviral air purification to be used in hospitals, nursing homes, dental offices, medical offices, and other healthcare facilities.

FDA Approves Bluezone 450 Medical Device

FDA approval for the Bluezone 450 came in February 2022, approximately a year after the company had initial evidence of the device’s effectiveness. The approval is validation that claims about the air filter are accurate, being verified not just by a third party but approved by one of the United States’ top federal medical agencies.

The Bluezone 450 air purifier has been approved as a Class II medical device, confirming high-level performance when used to kill airborne viruses. In its decision to approve the device, the FDA considered extensive evidence obtained through independent third-party testing. The air filter demonstrated the following results when used in a large room:

    • MS2 Bacteriophage was killed at a rate of 99.9995%
    • Mold was killed at a rate of 99.99%
    • Bacterial spores were killed at a rate of 99.99%
    • Stringent safety standards for continuous operation were met

The large room setting is akin to the spaces where medical facilities need air filtration, and the MS2 Bacteriophage is an accepted surrogate for the SARS-Cov-2 virus that causes Covid-19.

Thus, these claims were not only excellent and confirmed by the FDA. They’re also highly relevant to the current and future environment where airborne viruses are of significant concern.

The approval and completion of the 510(k) process was a major milestone in the model’s development and usage, as Chief Executive Officer Karen Benedek explained. “There are few options to decrease the risk associated with airborne viruses that do not create some discomfort and discord. Air cleaning with germicidal UV-C is a proven, effective virus reduction method for all occupied spaces. The process of FDA clearance is exhaustive, and we are very pleased that the Model 450 has achieved this milestone.”

The Bluezone 450 Air Purifier

The Bluezone 450 Air Purifier is the largest and most effective air purifier that Bluezone makes. It’s capable of treating rooms up to 9,000 cubic feet, and it has a 150 CFM flow rate that continuously circulates air for effective viral reduction. In addition to killing viruses, catalysts also destroy VOCs and odor-causing molecules.

The 450 Air Purifier is primarily intended for medical settings, but could also be installed in workspaces, schools, and dining facilities. Bluezone also has other models for these non-medical spaces.


Purify The Air You Breathe

Topics: Healthcare