Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030499299

FEI Number

3030499299

Entity Name

Inspire Medical Systems Inc

City/State/Country

Golden Valley, MN, US

Establishment Address

6105 Golden Hills Drive, Suite 100, Golden Valley, MN 55416, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Inspire Medical Systems Inc. (Owner Number: 10046749)

Owner / Operator Contact Address

5500 Wayzata Blvd., Suite 1600, Golden Valley, MN 55416, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P130008

All Registered Proprietary Names

Model 4063 Stimulation Lead Model 2740 Physician Programmer Model 3024 Implantable Pulse Generator Model 3032 Sleep Remote Model 3028 MR Conditional Implantable Pulse Generator Model 2500 Sleep Remote Model 4323 Sensing Lead Model 4340 Sensing Lead Model 2580 Sleep Remote SleepSync Model 2740C Inspire Programmer Cable SleepSync Model 2740S Inspire Programming Software Application Model 3150 MR Conditional Implantable Pulse Generator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNQ	Stimulator, Hypoglossal Nerve, Implanted, Apnea	Unknown	Class 3	N/A	2014-05-07

Official Correspondent

Joel Aaberg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Inspire Medical Systems Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007666314	INSPIRE MEDICAL SYSTEMS INC	Golden Valley, MN, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2025	Inspire Medical Systems Inc.	3	Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Z-0041-2025	Inspire Medical Systems Inc.	3	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030499299. Last updated year: 2026. Please use registration number 3030499299 when referencing this establishment in official correspondence.