FDA product code · Clinical chemistry
Test, System, Potassium, Enzymatic Method
4 FDA decisions since 2004. 510(k) reviews decided 2021–2025 took a median of 567 days (half between 567 and 567). 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 MZV 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 · MZV
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MZV
Too few MZV 510(k)s in any year since 2007 to give a median.
Recalls per year · MZV
No recall names MZV since 2007.
Adverse event reports per year · MZV
1in 2015
MAUDE reports naming product code MZV, 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 | 3 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 57 |
| 2012 | 0 | — | 0 | 32 |
| 2013 | 0 | — | 0 | 63 |
| 2014 | 0 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in MZV? 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 862.1600.