FDA product code · Cardiovascular
Shunt, Portosystemic, Endoprosthesis
3 FDA decisions since 1995. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MIR 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 · MIR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MIR
Too few MIR 510(k)s in any year since 2007 to give a median.
Recalls per year · MIR
No recall names MIR since 2007.
Adverse event reports per year · MIR
16in 2025
MAUDE reports naming product code MIR, 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 | 4 | — | 0 | 1 |
| 2008 | 6 | — | 0 | 4 |
| 2009 | 6 | — | 0 | 6 |
| 2010 | 5 | — | 0 | 8 |
| 2011 | 6 | — | 0 | 7 |
| 2012 | 10 | — | 0 | 9 |
| 2013 | 16 | — | 0 | 11 |
| 2014 | 7 | — | 0 | 8 |
| 2015 | 9 | — | 0 | 6 |
| 2016 | 9 | — | 0 | 8 |
| 2017 | 8 | — | 0 | 13 |
| 2018 | 10 | — | 0 | 20 |
| 2019 | 11 | — | 0 | 29 |
| 2020 | 8 | — | 0 | 14 |
| 2021 | 7 | — | 0 | 13 |
| 2022 | 6 | — | 0 | 23 |
| 2023 | 4 | — | 0 | 22 |
| 2024 | 6 | — | 0 | 40 |
| 2025 | 2 | — | 0 | 16 |
| 2026 | 2 | — | 0 | — |
Planning a device in MIR? 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