Data / Medical devices / United States / Inspire Medical Systems Inc
Inspire Medical Systems Inc: FDA-registered device maker in Golden Valley, MN, United States, 1 PMA approval
Inspire Medical Systems Inc is registered with the FDA (registration 3030499299) in Golden Valley, MN, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated April 30, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030499299
- Address
- 6105 Golden Hills Drive, Suite 100, Golden Valley, MN, United States, 55416
- Owner or operator
- Inspire Medical Systems Inc. (10046749)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 7, 2014
- Registered through
- 2026
- Brand names listed
- Model 2500 Sleep Remote, Model 2580 Sleep Remote, Model 2740 Physician Programmer, Model 3024 Implantable Pulse Generator, Model 3028 MR Conditional Implantable Pulse Generator, Model 3032 Sleep Remote, Model 3150 MR Conditional Implantable Pulse Generator, Model 4063 Stimulation Lead and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Hypoglossal Nerve, Implanted, Apnea | MNQ | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 30, 2014 | P130008 | INSPIRE II UPPER AIRWAY STIMULATOR | MNQ | 136 | October 22, 2026 | accessdata.fda.gov |
Compare with other makers
Updated October 22, 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.