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Inspire Medical Systems Inc: FDA-registered device maker in Golden Valley, MN, United States, 1 PMA approval

Name: Inspire Medical Systems Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Inspire Medical Systems Inc is registered with the FDA (registration 3007666314) in Golden Valley, MN, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated April 30, 2014. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3007666314
Address: 5500 Wayzata Blvd. Suite 1600, Golden Valley, MN, United States, 55416
Owner or operator: Inspire Medical Systems Inc. (10046749)
Roles: Complaint file establishment, 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
Instrument, Surgical, Non-Powered	HAO	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Stimulator, Hypoglossal Nerve, Implanted, Apnea	MNQ	3	Complaint file establishment, 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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 11, 2026	98990	Class II	Ongoing	Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respiratory Sensing Lead (Model 4340) is designed	Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.	accessdata.fda.gov
July 31, 2024	95230	Class II	Ongoing	Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.	Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.	accessdata.fda.gov
May 16, 2024	94658	Class I	Ongoing	Inspire Model 3028, IV Implantable Pulse Generator	There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG	accessdata.fda.gov
June 12, 2018	80372	Class II	Terminated	Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. Th	Incorrect use-by date on the device registration/patient file labels.	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.