FDA Cracks Down on Nasal Mask Maker for Product Claims

The FDA hit Phoenix, Arizona-based devicemaker CPAPNEA Medical Supply with a warning letter for marketing a device without premarket approval.

Although the company’s Optipillows expiratory positive airway pressure (EPAP) nasal mask received 510(k) clearance for reducing snoring in adults, its labeling and website claimed that  the device had been cleared for treating obstructive sleep apnea.

“Labeling found during FDA’s inspection shows that the Optipillows EPAP mask is intended to treat obstructive sleep apnea, which is a major change or modification from the cleared intended use of the device requiring a new 510(k), including appropriate performance data,” the agency said.