# PJJ: Two Or More Sterilant Sterilizer

- Device class: 2; regulation: 21 CFR 880.6860; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 2014: 1
- 2016: 2
- 2018: 2
- 2019: 1

## Most-cited predicates
- K141163: Sterizone Sterilizer (2014), cited by 3
- K153392: STERIZONE  VP4  Sterilizer (2016), cited by 2
- K153689: STERIZONE Sterilizer (2016), cited by 1
- K173694: STERIZONE VP4 Sterilizer (2018), cited by 1

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