FDA product code · Microbiology
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
33 FDA decisions since 2016. 510(k) reviews decided 2021–2025 took a median of 134 days (half between 89 and 300). 1 recall names this code; it is not Class I. The most-cited predicate is K182472, named by 4 later devices.
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PMN 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 · PMN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMN
90in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PMN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMN
1in 2023
MAUDE reports naming product code PMN, 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 | 3 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 59 | 0 | 0 |
| 2019 | 6 | 71 | 1 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 582 | 0 | 0 |
| 2023 | 4 | 90 | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 85 | 0 | — |
Planning a device in PMN? 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 866.3920.