# PLQ: Enzyme Packed Cartridge

- Device class: 2; regulation: 21 CFR 876.5985; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 96 days (middle half 82–108)
- 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)
- 2015: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2023: 2
- 2025: 2

## Most-cited predicates
- DEN150001: Relizorb (2015), cited by 3
- K161247: Relizorb (2016), cited by 2
- K163057: Relizorb (2017), cited by 1
- K232784: RELiZORB® (2023), cited by 1
- K191379: RELiZORB (2019), cited by 1
- K243284: RELiZORB (100300/ 100301) (2025), cited by 1
- K231156: Enzyme Packed Cartridge - RELiZORB (2023), cited by 1

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