Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007666314

FEI Number

3007666314

Entity Name

INSPIRE MEDICAL SYSTEMS INC

City/State/Country

Golden Valley, MN, US

Establishment Address

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

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

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

N/A

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 Model 5030 Tunneling Tool

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
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2025-07-15

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
3030499299	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.

Similar Registrations

Registration Number	Establishment Name	Location
3030499299	Inspire Medical Systems Inc	Golden Valley, MN, US
3017191859	NYXOAH SA	Mont-Saint-Guibert Brabant Wallon, BE
3030384719	Nyxoah SA Milmort	Herstal Liege, BE
3008851924	PRONAT INDUSTRIES LTD.	Emek Hefer Ind. Park Haifa, IL
3030384402	NYXOAH INC	Summit, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007666314. Last updated year: 2026. Please use registration number 3007666314 when referencing this establishment in official correspondence.