510(k) · Cleared
ClearedSunrise
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise SA · QRS Device For Sleep Apnea Testing Based On Mandibular Movement
Cleared on Aug 29, 2025 as substantially equivalent to K222262 (Sunrise SA, 2022) after a 158-day review. Its family tree reaches back 2 generations to 2022.
- Decided
- Aug 29, 2025
- Review
- 158 days
- Class
- Class II
- Product code
- QRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN210015 (2022). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QRS device
- #1 K222262 Sunrisescore 7.5 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222262 | SunriseSummary page 5…Regulatory Class: II Product Code: QRS Regulation: 21 CFR 868.2376 Classification Panel: Anesthesiology 3. PREDICATE DEVICE Predicate Device: Sunrise (K222262) Reference Device: SOMNOscreen plus (K201054) 4. DEVICE DESCRIPTION The Sunrise Air consists of the Sunrise software (… | 2022 |
| † | K201054 | SOMNOscreen plus | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QRS devicesQRS Device For Sleep Apnea Testing Based On Mandibular Movement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QRS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRS
Too few QRS 510(k)s in any year since 2007 to give a median.
Recalls per year · QRS
No recall names QRS since 2007.
Adverse event reports per year · QRS
No MAUDE report names QRS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sunrise Air 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250874: Sunrise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250874
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026