# NZA: Accessories, Germicide, Cleaning, For Endoscopes

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 59 days (middle half 26–101)
- 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)
- 1984: 1
- 1986: 1
- 2004: 1
- 2010: 1
- 2011: 1
- 2013: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 2

## Most-cited predicates
- K102244: Reliance Endoscope Processing System (2010), cited by 3
- K040049: The Reliance Endoscope Processing System (2004), cited by 1
- K123768: Reliance Advance Endoscope Processing System (2013), cited by 1
- K230560: enspire 300 Series Automated Endoscope Reprocessor System (2023), cited by 1
- K200989: Reliance Endoscope Processing System (2020), cited by 1
- K203223: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (2021), cited by 1

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