# JFP: Electrode, Ion Specific, Calcium

- Device class: 2; regulation: 21 CFR 862.1145; FDA's rule: 510(k) required
- FDA decisions: 29
- 510(k) review time 2021–2025: median 266 days (middle half 266–266)
- Recalls: 4 (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)
- 1993: 1
- 1994: 1
- 1995: 1
- 1996: 3
- 1997: 1
- 1998: 1
- 2016: 1
- 2019: 1
- 2020: 1
- 2023: 1

## Most-cited predicates
- K972673: Avl 9181 Electrolyte Analyzer (1997), cited by 7
- K961458: Avl 9180 Electrolyte Analyzer (1996), cited by 6
- K960120: Stat Profile Ultra F,G,H,I,J, and K Analyzers (1996), cited by 2
- K191360: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), cited by 2
- K984299: Avl Opti Critical Care Analyzer (1998), cited by 2
- K801848: ICA1 Ionized Calcium Analyzer (1980), cited by 1
- K963694: Easylyte Calcium/Chloride Analyzer (1996), cited by 1
- K844188: Corning Calcium PH Analyzer 634 (1985), cited by 1
- K943091: Easy Lyte Calcium Analyzer (1995), cited by 1

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