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 Dec 22, 2022 as substantially equivalent to DEN210015 (Sunrise, 2022) after a 147-day review. Its family tree reaches back 1 generation to 2022. 1 later device descends from it.
- Decided
- Dec 22, 2022
- Review
- 147 days
- Class
- Class II
- Product code
- QRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN210015 (2022). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K250874SunriseSunrise SA · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN210015 | Sunrise Sleep Disorder Diagnostic Aid | Sunrise | 2022 | — |
| 0 (this device) | K222262 | Sunrise | Sunrise SA | 2022 | — |
| +1 | K250874 | Sunrise | Sunrise SA | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 K250874 Sunrisescore 10.2 · 2 generations · 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 |
|---|---|---|---|
| * | DEN210015 | Sunrise Sleep Disorder Diagnostic AidSummary page 4…uct Code: QRS Regulation: 21 CFR 868.2376 Classification Panel: Anesthesiology 3. PREDICATE DEVICE Predicate Device: Sunrise Sleep Disorder Diagnostic Aid (DEN210015) Reference Devices: NightOwl (K191031), SOMNOscreen plus (K201054) 4. DEVICE DESCRIPTION The Sunrise device is a cloud-… | 2022 |
| † | K191031 | NightOwl | 2020 |
| † | K201054 | SOMNOscreen plus | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250874 | Sunrise | 2025 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K250874 (Sunrise SA, 2025) has gone furthest, with 0 descendants of its own.
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. 2022, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222262 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222262: Sunrise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222262
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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