Data / Medical devices / United States / Prosomnus Sleep Technologies
Prosomnus Sleep Technologies: FDA-registered device maker in Pleasanton, CA, United States, 6 510(k) clearances
Prosomnus Sleep Technologies is registered with the FDA (registration 3013116677) in Pleasanton, CA, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013116677
- Address
- 5675 Gibraltar Drive, Pleasanton, CA, United States, 94588
- Owner or operator
- ProSomnus Sleep Technologies (10053490)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 9, 2016
- Registered through
- 2026
- Brand names listed
- MicrO2 Sleep Device, MicrO2 Sleep Device with MicroRecorder, ProSomnus HWO2 Device, ProSomnus RPMO2 OSA Device, ProSomnus® EVO Sleep and Snore Device, ProSomnus® EVO Sleep and Snore Device with Patient Monitoring, ProSomnus® EVO [PH] Sleep and Snore Device, ProSomnus® EVO [PH] Sleep and Snore Device with Patient Monitoring and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sleep Appliances With Patient Monitoring | PLC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 6, 2026 | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | PLC | Substantially Equivalent | Prosomnus Sleep Technologies | accessdata.fda.gov |
| October 6, 2022 | K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring | LRK | Substantially Equivalent | Prosomnus Sleep Technologies | accessdata.fda.gov |
| November 20, 2020 | K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring | LRK | Substantially Equivalent | Prosomnus Sleep Technologies, Inc. | accessdata.fda.gov |
| November 22, 2017 | K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | PLC | Substantially Equivalent | Prosomnous Sleep Technologies | accessdata.fda.gov |
| November 7, 2016 | K161624 | MicrO2 OSA Device with Micro-Recorder | PLC | Substantially Equivalent | Microdental, Inc. | accessdata.fda.gov |
| July 24, 2014 | K133683 | MICR02 OSA DEVICE | LRK | Substantially Equivalent | Microdental, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Anti-Snoring
- All makers of Sleep Appliances With Patient Monitoring
- All makers of Device, Jaw Repositioning
- All makers of Oximeter, Wellness
- All makers of Medical Device Data System
- All makers of Oximeter
Updated April 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.