# PEX: System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

- Device class: 2; regulation: 21 CFR 866.3361; FDA's rule: 510(k) required
- FDA decisions: 5
- 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)
- 2013: 2
- 2015: 1
- 2017: 2

## Most-cited predicates
- DEN130013: Vitek MS (2013), cited by 3
- K130831: Maldi Biotyper CA (MBT-CA) System (2013), cited by 1
- K142677: MALDI Biotyper CA System (2015), cited by 1

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