FDA Clears Bluezone’s Model 450 Air Cleaner

Bluezone Products, which manufactures germicidal air cleaning products, has received the FDA’s 510(k) clearance for its Bluezone Model 450 air cleaner, which the agency has classified as a Class II medical device.

The freestanding device uses ultraviolet light to inactivate viral aerosols in medical facilities and other occupied spaces. The Woburn, Mass.-based company will market it to hospitals, nursing homes, and medical and dental offices to mitigate risks associated with the coronavirus.

Independent third-party testing in large, room-sized chambers showed that the Model 450 achieved a 99.99 percent kill of MS2 bacteriophage — an accepted SARS-CoV-2 surrogate — as well as a 99.99 percent kill of mold and bacterial spores, the company said.