FDA De Novo · Sunrise
DEN210015: Sunrise Sleep Disorder Diagnostic Aid (Sunrise)
Sunrise received FDA De Novo DEN210015 for Sunrise Sleep Disorder Diagnostic Aid, with a decision date of Jan 7, 2022.
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | DEN210015 |
|---|---|
| Pathway | De Novo |
| Applicant | Sunrise |
| Device name | Sunrise Sleep Disorder Diagnostic Aid |
| Product code | QRS: Device For Sleep Apnea Testing Based On Mandibular Movement |
| Regulation (21 CFR) | 868.2376 |
| Device class | Class 2 |
| Date received | Apr 2, 2021 |
| Decision date | Jan 7, 2022 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Sunrise SDDA device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.
Extracted automatically from FDA's decision summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions. 2 records in this database cite DEN210015 as a predicate (listed below).
Later records that cite DEN210015
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 868.2376). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Product code QRS is "Device For Sleep Apnea Testing Based On Mandibular Movement", class 2, 21 CFR 868.2376. FDA's definition: "A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor."
Our labels for filtering: claim Sleep apnea, sensor Other. These are heuristics, not FDA fields.