FDA product code · Neurology
Intracranial Aneurysm Flow Diverter
3 FDA decisions since 2011. 6 recalls name this code, 1 of them Class I.
Treatment of wide-necked and larger or giant intracranial aneurysms.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OUT 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 · OUT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OUT
Too few OUT 510(k)s in any year since 2007 to give a median.
Recalls per year · OUT
3so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OUT
1,625in 2025
MAUDE reports naming product code OUT, 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 | 3 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 335 |
| 2013 | 4 | — | 0 | 618 |
| 2014 | 3 | — | 0 | 438 |
| 2015 | 1 | — | 1 | 562 |
| 2016 | 1 | — | 1 (1) | 540 |
| 2017 | 1 | — | 0 | 448 |
| 2018 | 7 | — | 0 | 425 |
| 2019 | 5 | — | 0 | 528 |
| 2020 | 9 | — | 0 | 809 |
| 2021 | 13 | — | 0 | 850 |
| 2022 | 7 | — | 0 | 1,118 |
| 2023 | 8 | — | 0 | 1,186 |
| 2024 | 14 | — | 0 | 1,326 |
| 2025 | 10 | — | 1 | 1,625 |
| 2026 | 6 | — | 3 | — |
Planning a device in OUT? 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