iNAP One Sleep Therapy System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220907 FDA 510(k)
- FDA Product Code
- OZR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iNAP One Sleep Therapy System is an Intraoral Pressure Gradient Device, designed to deliver continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea. It features a compact, portable unit that integrates a humidifier and pressure regulator to maintain consistent airflow via an oral interface, reducing snoring and improving sleep quality.
This system is supplied as a reusable device with disposable components, including filters and tubing, and is intended for home use. It complies with FDA 510(k) clearance under the Dental advisory committee, adhering to Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. The system operates safely in non-MRI environments and requires proper storage in a clean, dry location to maintain functionality.
Frequently asked questions
What types of disposable components are included with the iNAP One Sleep Therapy System, and how often should they be replaced?
The iNAP One Sleep Therapy System includes disposable filters and tubing as part of its supply. These components are designed for single-use to ensure hygiene and optimal performance. Replacing them regularly helps maintain the system’s effectiveness and reduces the risk of contamination, which is especially important for home use in sleep therapy.
Is the iNAP One Sleep Therapy System safe to use in environments where MRI scans are performed, and why?
The iNAP One Sleep Therapy System is explicitly designed for use in non-MRI environments. This is because the device may contain metallic or electronic components that could interfere with MRI equipment or pose safety risks during scanning. Always ensure the device is removed and stored away from MRI areas to avoid potential hazards.
How should the iNAP One Sleep Therapy System be stored to maintain its functionality and longevity?
The system should be stored in a clean, dry location to prevent damage from moisture or dust. Proper storage ensures the device remains hygienic and operational for long-term use, particularly since it includes reusable components that require regular maintenance.
What regulatory pathways has the iNAP One Sleep Therapy System followed, and how does this affect its use?
The iNAP One Sleep Therapy System has undergone FDA 510(k) clearance under the Dental advisory committee, demonstrating substantial equivalence to existing devices. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards, ensuring it meets stringent European regulatory requirements. This clearance confirms its safety and effectiveness for delivering CPAP therapy in a home setting.
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 | K220907 | Class II | Active |
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Manufacturer
- Manufacturer
- Somnics, Inc.
Sources (2)
- FDA 510(k) K220907 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026