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FDA 510(k)

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

K-Number: K221889 · 2022-10-06

ApplicantProsomnus Sleep Technologies
Decision Date2022-10-06
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring is a medical device manufactured by Prosomnus Sleep Technologies. It received FDA 510(k) clearance on 2022-10-06 under approval number K221889. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring?

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring is a medical device that received FDA 510(k) clearance on 2022-10-06. It is manufactured by Prosomnus Sleep Technologies. The 510(k) number is K221889.

When was ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring approved by the FDA?

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring received FDA 510(k) clearance on 2022-10-06, under approval number K221889.

What company makes ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring?

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring is manufactured by Prosomnus Sleep Technologies.

What is the FDA product code for ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring?

The FDA product code for ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring is LRK.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 42065230 The need of innovation and of preservation of well-established techniques in the era of MDR for improving outcomes. EFORT open reviews (2026)

Other Devices by Prosomnus Sleep Technologies

K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)

Related Devices (Code: LRK)

K162192BlueProBluesom K152660HYPNOSPADSomnics, Inc. K161832O2VENT TOventus Manufacturing Pty, Ltd. K162306SomnoDent ALPHASomnomed, Inc. K160531NoiselezzFirma Ingemarsson K153200SnoreRxApnea Sciences Corporation

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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