# FKH: Solution-Test Standard-Conductivity, Dialysis

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 8
- 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)
- 1981: 1
- 1985: 1
- 1986: 1
- 2003: 1
- 2004: 2
- 2013: 1
- 2019: 1

## Most-cited predicates
- K851362: Standard Solution of Conductivity & Measurement of (1985), cited by 2
- K033330: Conductivity/TDS Calibrator Solution (2004), cited by 2
- K032075: Conductivity Standard Solution-Metercare (2003), cited by 1

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