FDA product code · Cardiovascular
Stent, Iliac
12 FDA decisions since 1996. 4 recalls name this code, 0 of them Class I.
Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NIO 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 · NIO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIO
Too few NIO 510(k)s in any year since 2007 to give a median.
Recalls per year · NIO
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NIO
632in 2025
MAUDE reports naming product code NIO, 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 | 3 | — | 0 | 38 |
| 2008 | 4 | — | 1 | 68 |
| 2009 | 7 | — | 0 | 97 |
| 2010 | 14 | — | 0 | 165 |
| 2011 | 23 | — | 0 | 256 |
| 2012 | 34 | — | 1 | 391 |
| 2013 | 47 | — | 0 | 395 |
| 2014 | 33 | — | 0 | 436 |
| 2015 | 27 | — | 1 | 445 |
| 2016 | 22 | — | 0 | 412 |
| 2017 | 18 | — | 0 | 462 |
| 2018 | 16 | — | 0 | 460 |
| 2019 | 22 | — | 1 | 416 |
| 2020 | 21 | — | 0 | 409 |
| 2021 | 12 | — | 0 | 421 |
| 2022 | 15 | — | 0 | 352 |
| 2023 | 16 | — | 0 | 351 |
| 2024 | 12 | — | 0 | 508 |
| 2025 | 14 | — | 0 | 632 |
| 2026 | 15 | — | 0 | — |
Planning a device in NIO? 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