ProSomnus Sleep Technologies Receives FDA Class II Clearance For RPMO2 OSA Device

Published: 2026-04-13 12:23:18 ET OSAPQ

Published on 04/13/2026 at 12:23 pm EDT

ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO2 OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device. This clearance affirms that the ProSomnus RPMO2 OSA Device meets the FDA?s standards for safety and effectiveness in measuring oxygen saturation (SpO2) and pulse rate, positioning the device as a cornerstone of a new Smart Sleep Medicine era characterized by connected, patient centric, evidence-driven OSA care.

The ProSomnus RPMO2 OSA Device is the first theragnostic device for sleep medicine, featuring a wholly embedded oximeter for safe, accurate and economical treatment and multi-night monitoring of OSA. The oximeter is encapsulated in an overlay of the maxillary dentition and uses the mucosa of the buccal vestibule behind the upper lip as the reflective tissue. Data are transmitted to a secure provider portal via patient smartphone app.

The RPMO2 OSA Device?s FDA clearance is supported by a rigorous, gold standard validation study conducted at the University of Calgary and published by Snow et al. (2025). The study evaluated the accuracy of the intraoral buccal mucosal oximeter against arterial oxyhemoglobin saturation measured using CO oximetry, the clinical gold standard for oxygen saturation measurement.

The study enrolled 12 healthy adults, consistent with ISO 80601 2 61 requirements, and included participants with a spectrum of skin pigmentation. Participants underwent six precisely controlled hypoxic plateaus, spanning ~97% to ~72% SaO2. Analysis of accuracy was performed on 325 SaO2/SpO2 data pairs and 346 pulse rate/ECG data pairs.

The RPMO2 OSA Device demonstrated strong clinical accuracy across the full range of 70-100% SaO2: Accuracy Root Mean Square (ARMS) for SpO2: 2.94%; Correlation between SpO2 and SaO2: r = 0.95; Bland-Altman: mean bias of 0.72, upper and lower 95% limits of agreement of 6.31 and -4.86, respectively; Consistent accuracy across entire range of SaO2 tested. The study reported no systematic bias across skin pigmentation groups. The buccal mucosa, which is thought to contain less melanin than the epidermis, may reduce the overestimation of oxygen saturation seen in conventional fingertip devices that measure through melanin-rich tissue.

The RPMO2 OSA Device also demonstrated excellent pulse rate measurement performance: ARMS: 2.08 beats per minute; Correlation between pulse rate and ECG: r = 0.99; Bland-Altman: mean bias of 0.30, upper and lower 95% limits of agreement of 4.34 and -3.73, respectively. The innovative intraoral design of the RPMO2 OSA Device addresses several long recognized limitations of conventional pulse oximeters: Motion artifact reduction: Stable placement high in the buccal vestibule minimizes motion-induced noise; High perfusion site: The buccal mucosa is richly vascularized, supporting high quality photoplethysmography; Thermal stability: The temperature-stable intraoral environment avoids temperature dependent perfusion variability; Intrinsic light shielding: The vestibular location protects the sensor from ambient light interference; Low melanin interference: Measurement through mucosa may reduce racial bias inherent in skin based oximetry. These attributes support the RPMO2 OSA Device?s suitability for accurate, nightly physiologic monitoring in real world settings.

The FDA clearance of the RPMO2 OSA Device unlocks Smart Sleep Medicine, ProSomnus?s next generation, connected care model for managing OSA as a chronic disease. The RPMO2 OSA Device enables: Longitudinal physiologic monitoring across nights and treatment stages; Evidence based, connected care workflows including remote physiologic monitoring (RPM); Real world insights enabling personalization of precision oral appliance therapy; Improved patient engagement and outcomes through continuous, comfortable monitoring.