FDA product code · Cardiovascular
Stent, Superficial Femoral Artery
12 FDA decisions since 2002. 81 recalls name this code, 1 of them Class I.
Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery 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 NIP 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 · NIP
34in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIP
Too few NIP 510(k)s in any year since 2007 to give a median.
Recalls per year · NIP
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NIP
837in 2025
MAUDE reports naming product code NIP, 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 | 5 | — | 0 | 32 |
| 2008 | 4 | — | 2 | 87 |
| 2009 | 21 | — | 0 | 152 |
| 2010 | 19 | — | 0 | 119 |
| 2011 | 17 | — | 72 | 119 |
| 2012 | 16 | — | 0 | 211 |
| 2013 | 21 | — | 1 (1) | 250 |
| 2014 | 42 | — | 0 | 403 |
| 2015 | 40 | — | 0 | 600 |
| 2016 | 50 | — | 1 | 846 |
| 2017 | 34 | — | 3 | 789 |
| 2018 | 56 | — | 0 | 546 |
| 2019 | 46 | — | 1 | 717 |
| 2020 | 33 | — | 0 | 802 |
| 2021 | 26 | — | 0 | 837 |
| 2022 | 26 | — | 0 | 831 |
| 2023 | 27 | — | 1 | 875 |
| 2024 | 29 | — | 0 | 1,013 |
| 2025 | 34 | — | 0 | 837 |
| 2026 | 24 | — | 0 | — |
Planning a device in NIP? 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