In a letter dated May 20, 2026, and published by the FDA this week, the agency said an inspection of U.S.-based distributor 3B Medical in Dublin, Ohio, identified issues with the CPAP machines developed by BMC. The investigation took place from Dec. 1, 2025, through Dec. 10, 2025.
BMC Medical has FDA 510(k) clearance for certain respiratory devices designed for treating sleep apnea. However, the inspection determined that the company failed to secure premarket approval for its G3X auto-adjusting positive airway pressure (APAP) system. It also has no approved application for investigational device exemption (IDE), the FDA said.
According to the FDA, BMC brought its devices to the U.S. market with significant changes but without submitting a new premarket notification to the FDA.
The agency said the company made significant changes or modifications to its Luna CPAP and Auto CPAP system. That system received FDA 510(k) clearance on Sept. 8, 2026. However, the FDA says the company updated firmware and software and modified the sound abatement system. Luna’s printed circuit board assembly also includes a new chip compatible with a new algorithm and data structure master control software.
“Collectively, these changes represent significant modifications in device design, materials, and software that could significantly affect the safety and effectiveness of the device,” the FDA wrote.
The inspection also determined that the company failed to submit a report for the Luna G3 APAP within 10 working days of initiating a correction or removal. BMC had not submitted a report of correction or removal to the FDA as of May 19, 2026.
“FDA requests that your firm cease any activities that result in the misbranding or adulteration of your devices,” the agency wrote.
