# PEO: Fungal Organisms, Nucleic Acid-Based Assay

- Device class: 2; regulation: 21 CFR 866.3365; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- Recalls: 0 (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)
- 2018: 1
- 2024: 1

## Most-cited predicates
- K182690: ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (2018), cited by 2

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