FDA product code · Cardiovascular
Catheter, Coronary, Atherectomy
5 FDA decisions since 1990. 9 recalls name this code, 2 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MCX 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 · MCX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCX
Too few MCX 510(k)s in any year since 2007 to give a median.
Recalls per year · MCX
2in 2022
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MCX
864in 2025
MAUDE reports naming product code MCX, 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 | 8 | — | 2 | 107 |
| 2008 | 8 | — | 0 | 185 |
| 2009 | 10 | — | 0 | 289 |
| 2010 | 5 | — | 0 | 319 |
| 2011 | 12 | — | 0 | 333 |
| 2012 | 10 | — | 0 | 293 |
| 2013 | 13 | — | 0 | 355 |
| 2014 | 18 | — | 0 | 412 |
| 2015 | 25 | — | 2 (2) | 629 |
| 2016 | 16 | — | 0 | 713 |
| 2017 | 23 | — | 0 | 735 |
| 2018 | 13 | — | 0 | 876 |
| 2019 | 15 | — | 1 | 788 |
| 2020 | 20 | — | 0 | 822 |
| 2021 | 9 | — | 1 | 901 |
| 2022 | 12 | — | 2 | 720 |
| 2023 | 18 | — | 0 | 706 |
| 2024 | 9 | — | 0 | 798 |
| 2025 | 10 | — | 0 | 864 |
| 2026 | 10 | — | 0 | — |
Planning a device in MCX? 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