Nuvo Nano Portable Oxygen Concentrator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192693 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 Nuvo Nano Portable Oxygen Concentrator is a Class II medical device designed as a portable oxygen generator. It delivers concentrated oxygen from ambient air to patients requiring supplemental oxygen therapy, utilizing advanced pressure swing adsorption technology to separate and concentrate oxygen molecules.
This device is intended for home use, clinical settings, and travel, providing continuous or pulse-dose oxygen delivery. Supplied as a reusable device, it requires no disposable components and is regulated under FDA 510(k) clearance (K192693) and EU MDR compliance. The unit operates on AC power or a rechargeable battery for portability, with no specific MRI safety restrictions noted. Storage conditions include protection from extreme temperatures and moisture.
Frequently asked questions
What types of settings can the Nuvo Nano Portable Oxygen Concentrator be used in, and how does its portability benefit patients?
The Nuvo Nano is designed for home use, clinical settings, and travel, making it versatile for patients who need oxygen therapy in multiple environments. Its portability comes from a rechargeable battery, allowing continuous operation away from power outlets—ideal for patients on the go or those who require oxygen outside traditional healthcare settings.
Does the Nuvo Nano require any disposable components, and how does this affect maintenance or cost?
No disposable components are needed with the Nuvo Nano—it’s a reusable device that relies solely on ambient air filtration and pressure swing adsorption technology. This eliminates ongoing replacement costs but requires proper cleaning and maintenance as specified in the manufacturer’s instructions to ensure longevity and performance.
What storage conditions should be followed to maintain the device’s functionality, and why are these important?
The device must be stored in a place protected from extreme temperatures and moisture to prevent operational issues. These conditions are critical because exposure to heat, cold, or humidity can degrade internal components (like the battery or filtration system) over time, potentially compromising oxygen delivery accuracy or device lifespan.
How does the Nuvo Nano’s regulatory pathway differ between the U.S. and Europe, and what does this imply for buyers?
In the U.S., the Nuvo Nano received FDA 510(k) clearance (K192693), indicating it’s classified as Substantially Equivalent to a predicate device and meets U.S. safety and effectiveness standards. In Europe, it complies with MDD and MDR, reflecting conformity with EU medical device regulations. Buyers should confirm local compliance requirements, as regulatory approvals may influence procurement or reimbursement processes.
Can the Nuvo Nano be used safely in environments with MRI machines, and if not, what alternatives should be considered?
The device’s documentation does not specify MRI safety restrictions, meaning it may not be explicitly tested or approved for use in MRI environments. Patients requiring oxygen therapy near MRI machines should consult their facility’s safety protocols or consider alternative portable oxygen solutions with documented MRI compatibility to avoid risks.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192693 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidek Medical Products Inc.
- FDA Applicant
- Nidek Medical Products, Inc.
Sources (2)
- FDA 510(k) K192693 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026