FDA product code · Immunology
System, Detection, Bacterial, For Platelet Transfusion Products
FDA lists MZC as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 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 MZC 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 · MZC
FDA has decided no MZC device since 2007.
Median 510(k) review, days · MZC
Too few MZC 510(k)s in any year since 2007 to give a median.
Recalls per year · MZC
No recall names MZC since 2007.
Adverse event reports per year · MZC
1in 2025
MAUDE reports naming product code MZC, 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 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
Planning a device in MZC? 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 866.2560.