# PLO: Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

- Device class: 2; regulation: 21 CFR 866.3970; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 1
- 2016: 1
- 2019: 1
- 2024: 1

## Most-cited predicates
- K160462: FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch (2016), cited by 2
- DEN150013: FilmArray Meningitis/Encephalitis (ME) Panel (2015), cited by 1

Source page: https://510kreport.com/product-code/PLO
Data by year (CSV): https://510kreport.com/product-code/PLO.csv