Data / Medical devices / United States / Somnetics International, Inc
Somnetics International, Inc: FDA-registered device maker in Fridley, MN, United States, 5 510(k) clearances
Somnetics International, Inc is registered with the FDA (registration 3008770104) in Fridley, MN, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 17, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008770104
- Address
- 103 Osborne Road NE, Fridley, MN, United States, 55432
- Owner or operator
- Somnetics International, Inc (10036212)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 22, 2011
- Registered through
- 2026
- Brand names listed
- MySleepDash Mobile Application, Transcend 3 miniCPAP, Transcend 3 miniCPAP Auto, Transcend 365 miniCPAP, Transcend 365 miniCPAP Auto, Transcend AirFlex, Transcend AirMist, Transcend Auto and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Specification developer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Specification developer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Manufacturer, Specification developer | 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 17, 2026 | K252338 | MySleepDash | BZD | Substantially Equivalent | Somnetics International, Inc. (Dba Transcend Inc) | accessdata.fda.gov |
| November 30, 2018 | K180388 | Transcend 365 miniCPAP System | BZD | Substantially Equivalent | Somnetics International, Inc. | accessdata.fda.gov |
| October 17, 2013 | K132127 | TRANSCEND AUTO | BZD | Substantially Equivalent | Somnetics International, Inc. | accessdata.fda.gov |
| September 26, 2013 | K131388 | TRANSCEND HEATED HUMIDIFIER | BTT | Substantially Equivalent | Somnetics International, Inc. | accessdata.fda.gov |
| July 13, 2010 | K100121 | MODEL 300157 CPAP SYSTEM | BZD | Substantially Equivalent | Aeiomed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Condenser, Heat And Moisture (Artificial Nose)
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Tubing, Pressure And Accessories
Updated April 17, 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.