Inogen One Oxygen Concentrator
FDA 510(k)Class II (US FDA 510(k))
by Inogen, Inc.
Identifiers
- 510(k) Number
- K032818 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Inogen One Oxygen Concentrator is a portable oxygen generator used to supply a high concentration of oxygen to patients requiring supplemental oxygen. It is a medical device designed to provide oxygen therapy.
The Inogen One Oxygen Concentrator is supplied as a single unit and is intended for use in various settings, including home and portable use. It has been cleared by the FDA with the regulation number 868.5440 and has a product code of CAW.
Frequently asked questions
What is the Inogen One Oxygen Concentrator used for?
The Inogen One Oxygen Concentrator is used to supply a high concentration of oxygen to patients requiring supplemental oxygen therapy in various settings, including home and portable use.
Is the Inogen One Oxygen Concentrator a single-use device?
The Inogen One Oxygen Concentrator is supplied as a single unit, but its intended use is for repeated, long-term oxygen therapy, not single-use.
What are the regulatory clearances for the Inogen One Oxygen Concentrator?
The Inogen One Oxygen Concentrator has been cleared by the FDA with the regulation number 868.5440 and has a product code of CAW, indicating its classification and approval for use in oxygen therapy.
What settings is the Inogen One Oxygen Concentrator intended for?
The Inogen One Oxygen Concentrator is intended for use in various settings, including home and portable use, providing flexibility for patients requiring supplemental oxygen therapy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Inogen Portable Oxygen Concentrators: America's leader, Inogen One G4 Portable Oxygen Concentrator | Inogen, Inogen Oxygen Concentrators and Inogen Respiratory Products, Leading Oxygen Concentrator Technology on the Market | Inogen, Inc, PDF INOGENONE - Oxygen Concentrator Store
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032818 | Class II | Active |
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Manufacturer
- Manufacturer
- Inogen, Inc.
Sources (1)
- FDA 510(k) K032818 24 fields · synced Sep 24, 2026