# MNV: Strip, Dialysate Ph Indicator

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 1995: 4
- 2003: 1
- 2011: 1

## Most-cited predicates
- K936311: Mitek Mini Anchor (1995), cited by 2
- K945491: Serim (TM) Bicarb PH Reagent Strips (1995), cited by 1

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