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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 the device name listed in this FDA 510(k) record. The listed applicant is Prosomnus Sleep Technologies. It received FDA 510(k) clearance on 2026-04-06 under 510(k) 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. The listed applicant is Prosomnus Sleep Technologies. The 510(k) number is K252765.

When did ProSomnus RPMO2 OSA Device (RPMO2 OSA) receive FDA 510(k) clearance?

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

Who is the listed applicant for ProSomnus RPMO2 OSA Device (RPMO2 OSA)?

The FDA 510(k) record lists Prosomnus Sleep Technologies as the applicant. This does not by itself establish the device manufacturer.

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 records listing Prosomnus Sleep Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient MonitoringK202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

Related Devices (Code: PLC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233497Rest Assure SystemSomnomed, Inc.K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep ServicesK181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc.K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep TechnologiesK170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic LabK161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc.

Official Source

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

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