# K252765: ProSomnus RPMO2 OSA Device (RPMO2 OSA)

- Pathway: 510(k) (Traditional)
- Applicant: Prosomnus Sleep Technologies
- Decided: Apr 6, 2026 after 220 days
- Product code: PLC (Sleep Appliances With Patient Monitoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K882303 (1989). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202529: ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring, Prosomnus Sleep Technologies, Inc. (2020) Summary page 5.

## Most influential descendants
- K254304: iNOS intraoral biosensor (2026), 0 descendants of its own

## Indications for use
The ProSomnus® RPMO2 OSA Device is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Additionally, the fully embedded RPMO2 oximeter sensor measures, displays, stores, and transmits functional oxygen saturation of the arterial hemoglobin (SpO2) and pulse rate. It is intended for continuous data collection during sleep. It can be used in home settings, sleep laboratories, long-term care facilities, and hospitals. When used in combination with the ProSomnus® Oxymetrx™ App and ProSomnus® Oxymetrx™ Provider Portal, the device enables remote collection of patients’ physiological data. The device is intended to be applied in the oral cavity. The device is intended for use under non-motion conditions in well-perfused areas. The device is single patient, reusable.

Source page: https://510kreport.com/device/K252765
Methodology: https://510kreport.com/methodology