# CDS: Electrode, Ion Specific, Urea Nitrogen

- Device class: 2; regulation: 21 CFR 862.1770; FDA's rule: 510(k) required
- FDA decisions: 15
- Recalls: 1 (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)
- 1976: 1
- 1977: 2
- 1979: 1
- 1980: 3
- 1981: 2
- 1986: 2
- 1993: 1
- 2004: 2
- 2018: 1

## Most-cited predicates
- K171247: epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (2018), cited by 1
- K761061: Blood-Urea-Nitrogen (Bun) Analyzer 2 (1977), cited by 1

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