FDA product code · Anesthesiology
Over-The-Counter Device To Assess Risk Of Sleep Apnea
3 FDA decisions since 2024. 510(k) reviews decided 2021–2025 took a median of 162 days (half between 162 and 162). No recall names this code. The most-cited predicate is DEN230041, named by 2 later devices.
An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g.…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QZW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · QZW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QZW
Too few QZW 510(k)s in any year since 2007 to give a median.
Recalls per year · QZW
No recall names QZW since 2007.
Adverse event reports per year · QZW
2in 2025
MAUDE reports naming product code QZW, not matched to any one device; reports are not rates.
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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
Planning a device in QZW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report