# MSY: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

- Device class: 2; regulation: 21 CFR 876.5665; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 101 days (middle half 95–107)
- 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)
- 1998: 2
- 1999: 1
- 2000: 2
- 2001: 1
- 2008: 1
- 2009: 1
- 2014: 1
- 2020: 1
- 2022: 1
- 2025: 1

## Most-cited predicates
- K983997: Sterichek Total Chlorine Test Kit (1999), cited by 1
- K090338: Ultra Low Total Chlorine, E-Z Chek Sensitive Total Chlorine (2009), cited by 1
- K001194: Sterichek Total Chlorine Reagent Strips (2000), cited by 1
- K193169: Nelson Sentinel Series Basic Chlorine Sentinel (2020), cited by 1

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