# PMY: System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 871 days (middle half 871–871)
- 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)
- 2016: 1
- 2019: 1
- 2021: 1

## Most-cited predicates
- K152614: Xpert Carba-R (2016), cited by 3

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