FDA product code · Hematology
Fibrin Sealant Preparation Device
0 FDA decisions. 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 MZM 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 · MZM
FDA has decided no MZM device since 2007.
Median 510(k) review, days · MZM
Too few MZM 510(k)s in any year since 2007 to give a median.
Recalls per year · MZM
No recall names MZM since 2007.
Adverse event reports per year · MZM
79in 2025
MAUDE reports naming product code MZM, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 38 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 0 | — | 0 | 103 |
| 2023 | 0 | — | 0 | 47 |
| 2024 | 0 | — | 0 | 82 |
| 2025 | 0 | — | 0 | 79 |
| 2026 | 0 | — | 0 | — |
Planning a device in MZM? 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) ReportRelated product codes
Other codes under 21 CFR 880.5860.