Company
Inspire Medical Systems Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (2 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Inspire Medical Systems Inc. Brand Name: Inspire Medical Systems, Inc.
Product Name: Inspire stimulation Lead
Model/Catalog Number: 4063
Product Description: The Inspire Stimulation Lead (Model 4063) is designed to deliver stimul Open, Classified |
MNQ | None listed |
| Jun 18, 2026 | Inspire Medical Systems Inc. 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 (Mod Open, Classified |
MNQ | None listed |
| Oct 9, 2024 | Inspire Medical Systems Inc. Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system. Open, Classified |
MNQ | None listed |
| Oct 9, 2024 | Inspire Medical Systems Inc. Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system. Open, Classified |
MNQ | None listed |
| Jun 21, 2024 | Inspire Medical Systems Inc. Inspire Model 3028, IV Implantable Pulse Generator Open, Classified |
MNQ | None listed |
| Jun 12, 2018 | Inspire Medical Systems Inc. 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 Stimu Terminated |
MNQ | None listed |