FDA product code · Cardiovascular
System, Oxygen, Aqueous
1 FDA decision since 2019. 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 MWG 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 · MWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWG
Too few MWG 510(k)s in any year since 2007 to give a median.
Recalls per year · MWG
No recall names MWG since 2007.
Adverse event reports per year · MWG
1in 2025
MAUDE reports naming product code MWG, 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 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 7 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
Planning a device in MWG? 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