# PEN: Gram-Negative Bacteria And Associated Resistance Markers

- Device class: 2; regulation: 21 CFR 866.3365; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 203 days (middle half 109–206)
- Recalls: 3 (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)
- 2014: 1
- 2015: 1
- 2016: 1
- 2018: 1
- 2019: 2
- 2020: 1
- 2022: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K130914: Filmarray Blood Culture Identification (Bcid) Panel (2013), cited by 4
- K132843: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) (2014), cited by 2
- K182619: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (2019), cited by 2
- K193519: BioFire Blood Culture Identification 2 (BCID2) Panel (2020), cited by 1
- K181493: FilmArray Blood Culture Identification (BCID) Panel (2018), cited by 1
- K143171: FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 (2015), cited by 1

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