FDA Clears ProSomnus RPMO2 Sleep Apnea Oral Device With Built-In Oximeter

The US Food and Drug Administration has cleared ProSomnus Sleep Technologies' RPMO2 OSA Device, an oral appliance for obstructive sleep apnea with a pulse oximeter built into it, the company said in an April 13 release distributed by GlobeNewswire, read on BioSpace.

Oral appliances for sleep apnea, often called mandibular advancement devices, hold the lower jaw forward during sleep to keep the airway open. ProSomnus's device adds a sensor that records blood oxygen and pulse rate each night and sends the data to clinicians.

What the FDA cleared

The FDA's 510(k) database lists the device under K252765, received on August 29, 2025, with a substantially equivalent decision on April 6, 2026. Its primary product code covers sleep appliances with patient monitoring.

According to the clearance letter and 510(k) summary, the device "is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults." Its embedded oximeter measures, displays, stores and transmits oxygen saturation and pulse rate for continuous data collection during sleep, and can be used at home, in sleep laboratories, in long-term care facilities and in hospitals. Paired with the company's Oxymetrx app and provider portal, it allows remote collection of patient data. The summary adds that the device is intended for use under non-motion conditions in well-perfused areas.

The summary names ProSomnus's own EVO Sleep and Snore Device with Patient Monitoring as the predicate and a Checkme O2 pulse oximeter as a reference device. It describes the appliance as a prescription, patient-specific device made of custom-fitted upper and lower arches, with the sensor sealed inside the upper arch and powered by a rechargeable battery.

Company-reported accuracy data

ProSomnus said the clearance is supported by a validation study at the University of Calgary published by Snow and colleagues in 2025. The study enrolled 12 healthy adults, including people across a range of skin pigmentation, who went through six controlled low-oxygen plateaus from about 97% to about 72% arterial oxygen saturation. The company reported an accuracy root mean square of 2.94% for oxygen saturation and 2.08 beats per minute for pulse rate.

The company said the study found no systematic bias across skin pigmentation groups. It argues that measuring through the lining of the cheek, which it said is thought to contain less melanin than skin, may reduce the overestimation of oxygen levels seen with fingertip devices in people with darker skin. That is the company's characterization of its own study.

ProSomnus describes the product as the first "theragnostic" device for sleep medicine, combining therapy and monitoring in one appliance. "By integrating safe, accurate, continuous physiologic measurement into our precision oral appliance platform, we are enabling Smart Sleep Medicine," Chief Executive Len Liptak said in the release.

The company said the device will support remote physiologic monitoring workflows. It did not give pricing or a launch date in the release.