FDA product code · Dental
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
5 FDA decisions since 2008. 1 recall names this code; it is not Class I. The most-cited predicate is K071560, named by 3 later devices.
Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OHP 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 · OHP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OHP
Too few OHP 510(k)s in any year since 2007 to give a median.
Recalls per year · OHP
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHP
1in 2017
MAUDE reports naming product code OHP, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in OHP? 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) ReportRelated product codes
Other codes under 21 CFR 872.5570.