FDA product code · Cardiovascular
Device, Hemostasis, Vascular
19 FDA decisions since 1995. 7 recalls name this code, 0 of them Class I. The most-cited predicate is P010049, named by 1 later device.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MGB 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 · MGB
18in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MGB
Too few MGB 510(k)s in any year since 2007 to give a median.
Recalls per year · MGB
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGB
12,664in 2025
MAUDE reports naming product code MGB, 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 | 18 | — | 0 | 1,588 |
| 2008 | 20 | — | 0 | 2,267 |
| 2009 | 34 | — | 1 | 2,436 |
| 2010 | 22 | — | 0 | 3,933 |
| 2011 | 23 | — | 0 | 4,011 |
| 2012 | 16 | — | 1 | 3,786 |
| 2013 | 12 | — | 0 | 3,011 |
| 2014 | 26 | — | 0 | 4,468 |
| 2015 | 28 | — | 0 | 3,944 |
| 2016 | 26 | — | 0 | 4,330 |
| 2017 | 15 | — | 0 | 5,346 |
| 2018 | 23 | — | 0 | 5,679 |
| 2019 | 27 | — | 0 | 6,156 |
| 2020 | 10 | — | 0 | 5,927 |
| 2021 | 17 | — | 0 | 7,586 |
| 2022 | 11 | — | 0 | 9,457 |
| 2023 | 18 | — | 2 | 13,529 |
| 2024 | 22 | — | 0 | 13,762 |
| 2025 | 18 | — | 0 | 12,664 |
| 2026 | 24 | — | 0 | — |
Planning a device in MGB? 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