FDA product code · Cardiovascular
System, Laser, Transmyocardial Revascularization
2 FDA decisions since 1998. 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 MNO 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 · MNO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MNO
Too few MNO 510(k)s in any year since 2007 to give a median.
Recalls per year · MNO
No recall names MNO since 2007.
Adverse event reports per year · MNO
2in 2022
MAUDE reports naming product code MNO, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 5 | — | 0 | 15 |
| 2013 | 1 | — | 0 | 59 |
| 2014 | 3 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 14 |
| 2016 | 3 | — | 0 | 6 |
| 2017 | 4 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in MNO? 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