FDA 510(k) · Sunrise
K222262: Sunrise (Sunrise SA)
Sunrise SA received FDA 510(k) K222262 for Sunrise, with a decision date of Dec 22, 2022 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: Form 3881 Type of Use (parsed))
FDA facts
| FDA number | K222262 |
|---|---|
| Pathway | 510(k) |
| Applicant | Sunrise SA |
| Device name | Sunrise |
| Product code | QRS: Device For Sleep Apnea Testing Based On Mandibular Movement |
| Regulation (21 CFR) | 868.2376 |
| Device class | Class 2 |
| Date received | Jul 28, 2022 |
| Decision date | Dec 22, 2022 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Sunrise 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 510(k) 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
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K222262
- K250874 Sunrise (Sunrise, Aug 29, 2025, QRS)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. 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.