FDA product code · Microbiology
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
4 FDA decisions since 2015. 510(k) reviews decided 2021–2025 took a median of 90 days (half between 90 and 90). 1 recall names this code; it is not Class I. The most-cited predicate is K160462, named by 2 later devices.
A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PLO 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 · PLO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PLO
Too few PLO 510(k)s in any year since 2007 to give a median.
Recalls per year · PLO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLO
4in 2025
MAUDE reports naming product code PLO, 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 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 3 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
Planning a device in PLO? 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