FDA product code · Cardiovascular
Scaffold, Infrapopliteal, Absorbable
1 FDA decision since 2024. No recall names this code.
The absorbable scaffold is for improving luminal diameter for the treatment of lesions in native infrapopliteal arteries.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NXW 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 · NXW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NXW
Too few NXW 510(k)s in any year since 2007 to give a median.
Recalls per year · NXW
No recall names NXW since 2007.
Adverse event reports per year · NXW
104in 2025
MAUDE reports naming product code NXW, 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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 10 | — | 0 | 29 |
| 2025 | 7 | — | 0 | 104 |
| 2026 | 3 | — | 0 | — |
Planning a device in NXW? 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