Sunrise Sleep Disorder Diagnostic Aid
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Sunrise
Identifiers
- 510(k) Number
- DEN210015 FDA 510(k)
- FDA Product Code
- QRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2376 FDA 510(k)
- Regulation Number
- 868.2376 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Sunrise Sleep Disorder Diagnostic Aid (SDDA) is a Device for Sleep Apnea Testing Based on Mandibular Movement, classified under FDA regulation 868.2376. It is a non-invasive diagnostic tool designed to evaluate obstructive sleep apnea (OSA) by monitoring mandibular movement during sleep, providing objective data for sleep breathing disorder assessment in adult patients aged 18 and older.
The SDDA is a single-use, non-invasive device intended for home use, featuring an 8-gram sensor for mandibular movement detection. Supplied as a ready-to-use kit, it requires no sterilisation and is regulated under FDA 510(k) clearance (K-number: DEN210015) and EU MDR compliance. Storage conditions are not specified in the data, but its non-invasive, disposable design ensures ease of use in clinical or home settings without MRI restrictions.
Frequently asked questions
How does the Sunrise Sleep Disorder Diagnostic Aid help diagnose sleep apnea, and who is it intended for?
The Sunrise Sleep Disorder Diagnostic Aid detects obstructive sleep apnea (OSA) by monitoring mandibular (jaw) movement during sleep. It provides objective data for assessing sleep breathing disorders in adult patients aged 18 and older. The lightweight 8-gram sensor tracks movement non-invasively, making it suitable for home or clinical use without requiring specialized equipment.
Is the Sunrise Sleep Disorder Diagnostic Aid reusable, and if not, how is it supplied?
No, the Sunrise Sleep Disorder Diagnostic Aid is designed for single-use only. It comes as a ready-to-use kit, eliminating the need for sterilization or preparation before use. This ensures hygiene and convenience for both clinical and home-based diagnostic testing.
What storage requirements should I consider for the Sunrise Sleep Disorder Diagnostic Aid?
The provided data does not specify exact storage conditions, but as a non-invasive, single-use device, it does not require refrigeration or specialized handling. Standard room-temperature storage should suffice, though users should follow general best practices for medical devices to maintain integrity until use.
What regulatory pathways does the Sunrise Sleep Disorder Diagnostic Aid follow, and which governing bodies have approved it?
The device is cleared under the FDA 510(k) pathway with clearance number DEN210015 and complies with the EU Medical Device Regulation (MDR). It falls under FDA classification 868.2376 for sleep apnea testing based on mandibular movement, ensuring it meets both U.S. and EU regulatory standards for diagnostic use.
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: PDF DEN210015, Sunrise Sleep Disorder Diagnostic Aid (SDDA), Sunrise SA, Sunrise Sleep Apnea Test - Sunrise, Sunrise Sleep Disorder Diagnostic Aid (DEN210015) — FDA 510 (k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | DEN210015 | Class II | Active |
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Manufacturer
- Manufacturer
- Sunrise
Sources (2)
- FDA 510(k) DEN210015 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026