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Sign in to claim this brandInspire Medical Systems
US
Last updated September 17, 2026
What Inspire Medical Systems makes
The company develops implantable vagus nerve stimulation systems designed to treat epilepsy and psychiatric conditions, as well as respiration-sensing devices for obstructive sleep apnoea. These systems are intended for long-term use and deliver targeted electrical stimulation to modulate nerve activity. The portfolio includes a single primary product line, the Inspire system, which combines sensing and stimulation capabilities for sleep apnoea management. The vagus nerve stimulation devices are intended for patients with refractory seizure disorders or specific psychiatric conditions, while the sleep apnoea system is designed to reduce airway collapse during sleep.
All devices fall under Class III regulation, requiring a Premarket Approval (PMA) or Unique Device Identifier (UDI) listing with the FDA. The company’s products are authorised for commercial distribution in the United States. No additional regulatory registries or international authorisations are referenced in the available data.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Inspire Medical Systems manufacture?
Inspire Medical Systems specialises in implantable medical devices that stimulate the vagus nerve for therapeutic purposes. Their primary focus is on systems designed to treat epilepsy and psychiatric conditions through electrical stimulation. Additionally, they develop respiration-sensing devices for managing obstructive sleep apnoea, which detect breathing patterns and deliver targeted stimulation to prevent airway collapse during sleep. These devices are intended for long-term use and are part of a single product line called the Inspire system.
Where is Inspire Medical Systems based, and where are their devices authorised for use?
Inspire Medical Systems is based in the United States. Their devices are authorised for commercial distribution in the US through regulatory pathways such as Premarket Approval (PMA) and Unique Device Identifier (UDI) listings with the FDA. No other regulatory registries or international authorisations are referenced in the available data.
Which regulatory registries list Inspire Medical Systems’ devices?
Inspire Medical Systems’ devices are listed under the FDA’s Premarket Approval (PMA) and Unique Device Identifier (UDI) registries. These pathways are required for Class III devices, which include their vagus nerve stimulation systems and sleep apnoea treatment devices. The FDA’s classification ensures these devices meet stringent safety and effectiveness standards before authorisation.
How are Inspire Medical Systems’ devices classified under regulatory standards?
Inspire Medical Systems’ devices fall under Class III regulation, the highest risk category under FDA classification. This classification applies to products that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. Due to this classification, each device requires rigorous review through a Premarket Approval (PMA) application or UDI listing to ensure safety and efficacy before commercial distribution.
What is the primary purpose of the Inspire system developed by Inspire Medical Systems?
The Inspire system developed by Inspire Medical Systems serves dual therapeutic purposes: it treats epilepsy and psychiatric conditions through vagus nerve stimulation, and it manages obstructive sleep apnoea by sensing respiration and delivering targeted electrical stimulation to prevent airway obstruction during sleep. The system combines sensing and stimulation capabilities into a single implantable device, making it versatile for these two distinct medical applications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 5500 Wayzata Blvd. Suite 1600, Golden Valley, MN, 55416
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3007666314
- DUNS Number
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Catalogue (60)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Inspire | 900-004-051 | FDA UDI | Class III | Active |
| Inspire | 900-001-008 | FDA UDI | Class III | Active |
| Inspire | 900-003-015 | FDA UDI | Class III | Active |
| Inspire | 900-015-001 | FDA UDI | Class III | Active |
| Inspire | 900-004-111 | FDA UDI | Class III | Active |
| Inspire | 900-004-116 | FDA UDI | Class III | Active |
| Inspire | 900-013-001 | FDA UDI | Class III | Unknown |
| Inspire | 900-008-000 | FDA UDI | Class III | Active |
| Inspire | 900-007-017 | FDA UDI | Class III | Active |
| Inspire | 900-029-001 | FDA UDI | Class III | Active |
| Inspire | 900-004-031 | FDA UDI | Class III | Active |
| Inspire | 900-017-005 | FDA UDI | Class III | Active |
| Inspire | 900-002-007 | FDA UDI | Class III | Active |
| Inspire | 900-013-003 | FDA UDI | Class III | Active |
| Inspire | 900-007-010 | FDA UDI | Class III | Active |
| Inspire | 900-009-002 | FDA UDI | Class III | Active |
| Inspire | 900-000-016 | FDA UDI | Class III | Active |
| Inspire | 900-004-102 | FDA UDI | Class III | Active |
| Inspire | 900-008-003 | FDA UDI | Class III | Active |
| Inspire | 900-004-041 | FDA UDI | Class III | Active |
| Inspire | 900-014-003 | FDA UDI | Class III | Active |
| Inspire | 900-017-0051 | FDA UDI | Class III | Active |
| Inspire | 900-007-014 | FDA UDI | Class III | Active |
| Inspire | 900-017-001 | FDA UDI | Class III | Active |
| Inspire | 900-009-003 | FDA UDI | Class III | Active |
| Inspire | 900-001-010 | FDA UDI | Class III | Active |
| Inspire | 900-002-007 | FDA UDI | Class III | Active |
| Inspire | 900-017-053 | FDA UDI | Class III | Active |
| Inspire | 900-004-073 | FDA UDI | Class III | Active |
| Inspire | 900-002-009 | FDA UDI | Class III | Active |
| Inspire | 900-002-010 | FDA UDI | Class III | Active |
| Inspire | 900-001-007 | FDA UDI | Class III | Active |
| Inspire | 900-001-005 | FDA UDI | Class III | Active |
| Inspire | 900-002-008 | FDA UDI | Class III | Active |
| Inspire | 900-018-001 | FDA UDI | Class III | Active |
| Inspire | 900-001-011 | FDA UDI | Class III | Active |
| Inspire | 900-013-001 | FDA UDI | Class III | Active |
| Inspire | 900-007-019 | FDA UDI | Class III | Active |
| Inspire | 900-004-071 | FDA UDI | Class III | Active |
| Inspire | 900-004-115 | FDA UDI | Class III | Active |
| Inspire | 900-004-117 | FDA UDI | Class III | Active |
| Inspire | 900-014-005 | FDA UDI | Class III | Active |
| Inspire | 900-007-008 | FDA UDI | Class III | Active |
| Inspire | 900-008-053 | FDA UDI | Class III | Active |
| Inspire | 900-001-007 | FDA UDI | Class III | Active |
| Inspire | 900-017-003 | FDA UDI | Class III | Active |
| Inspire | 900-004-061 | FDA UDI | Class III | Active |
| Inspire | 900-004-071 | FDA UDI | Class III | Active |
| Inspire | 900-026-001 | FDA UDI | Class III | Active |
| Inspire | 900-008-051 | FDA UDI | Class III | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Inspire Medical Systems has four FDA recall records initiated between June 12, 2018, and July 31, 2024. The records reflect one classified, one open, and two terminated recalls, with reasons including incorrect use-by dates on device labels, a potential manufacturing defect causing electrical leakage in the sensing circuit, and a labeling mismatch between shelf box serial numbers and lead serial numbers.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 31, 2024 | Z-0041-2025 | — | open, classified | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| Jul 31, 2024 | Z-0040-2025 | — | open, classified | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| May 16, 2024 | Z-2159-2024 | — | open, classified | 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, |
| Jun 12, 2018 | Z-2969-2018 | — | terminated | Incorrect use-by date on the device registration/patient file labels. |