FDA product code · Neurology
Intrasaccular Flow Disruption Device
1 FDA decision since 2018. 1 recall names this code; it is not Class I.
An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OPR 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 · OPR
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OPR
Too few OPR 510(k)s in any year since 2007 to give a median.
Recalls per year · OPR
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OPR
218in 2025
MAUDE reports naming product code OPR, 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 | 1 | — | 0 | 21 |
| 2020 | 3 | — | 0 | 11 |
| 2021 | 6 | — | 0 | 59 |
| 2022 | 1 | — | 1 | 62 |
| 2023 | 3 | — | 0 | 119 |
| 2024 | 3 | — | 0 | 262 |
| 2025 | 0 | — | 0 | 218 |
| 2026 | 3 | — | 0 | — |
Planning a device in OPR? 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