FDA Clears Belluscura’s Portable Oxygen Concentrator, X-plo2r

The US FDA has issued 510(k) clearance and marketing authorization to the X-plo₂r portable oxygen concentrator from Belluscura PLC and Separation Design Group.

Weighing less than 3.25 lbs (1.5 kg), the X-plo₂r POC has patented technology that can deliver up to 95% pure oxygen to patients and is designed to replace oxygen tanks and heavier portable oxygen concentrators for patients with COPD or COVID-19-related respiratory distress.

“Belluscura researched the portable oxygen market and concluded that new technology could improve the quality and efficiency of oxygen concentrators while also reducing the cost to the patient and caregiver,” Belluscura CEO Robert Rauker said in a press release.

The device will be commercially launched in 2021, according to Belluscura.