FDA product code · Anesthesiology
High Flow/High Velocity Humidified Oxygen Delivery Device
3 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 242 days (half between 232 and 253). No recall names this code. The most-cited predicate is DEN170001, named by 2 later devices.
Intended to deliver high flow and/or high velocity oxygen with humidification.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QAV 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 · QAV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QAV
Too few QAV 510(k)s in any year since 2007 to give a median.
Recalls per year · QAV
No recall names QAV since 2007.
Adverse event reports per year · QAV
10in 2025
MAUDE reports naming product code QAV, 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 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
Planning a device in QAV? 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