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FDA 510(k)

ProSomnus RPMO2 OSA Device (RPMO2 OSA)

K-Number: K252765 · 2026-04-06

ApplicantProsomnus Sleep Technologies
Decision Date2026-04-06
Product CodePLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ProSomnus RPMO2 OSA Device (RPMO2 OSA) is a medical device manufactured by Prosomnus Sleep Technologies. It received FDA 510(k) clearance on 2026-04-06 under approval number K252765. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProSomnus RPMO2 OSA Device (RPMO2 OSA)?

ProSomnus RPMO2 OSA Device (RPMO2 OSA) is a medical device that received FDA 510(k) clearance on 2026-04-06. It is manufactured by Prosomnus Sleep Technologies. The 510(k) number is K252765.

When was ProSomnus RPMO2 OSA Device (RPMO2 OSA) approved by the FDA?

ProSomnus RPMO2 OSA Device (RPMO2 OSA) received FDA 510(k) clearance on 2026-04-06, under approval number K252765.

What company makes ProSomnus RPMO2 OSA Device (RPMO2 OSA)?

ProSomnus RPMO2 OSA Device (RPMO2 OSA) is manufactured by Prosomnus Sleep Technologies.

What is the FDA product code for ProSomnus RPMO2 OSA Device (RPMO2 OSA)?

The FDA product code for ProSomnus RPMO2 OSA Device (RPMO2 OSA) is PLC.

Other Devices by Prosomnus Sleep Technologies

K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring

Related Devices (Code: PLC)

K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. K160239TAP 3, TAP 1Airway Management, Inc. K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep Technologies K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc. K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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