# CEM: Electrode, Ion Specific, Potassium

- Device class: 2; regulation: 21 CFR 862.1600; FDA's rule: 510(k) required
- FDA decisions: 89
- 510(k) review time 2021–2025: median 273 days (middle half 217–433)
- Recalls: 34 (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)
- 2006: 4
- 2007: 1
- 2009: 1
- 2010: 3
- 2011: 3
- 2012: 4
- 2020: 1
- 2023: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K042291: Unicel DXC 600 and 800 Synchron Systems (2004), cited by 6
- K092686: ABL90 Flex Series (2010), cited by 6
- K060373: Cobas 6000 Series System (2006), cited by 6
- K974784: Avl Opti Critical Care Analyzer (1998), cited by 3
- K093318: Accelerator Aps (2010), cited by 2
- K112995: Gem Premier 4000 (2012), cited by 2
- K854298: IRON (1985), cited by 2
- K052914: RX Imola (2006), cited by 2
- K061107: DPC T60I Kusti, Model 984248; DPC T60I, Model 984247 (2006), cited by 1
- K083680: Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+DT Slides: 153 2258 (2009), cited by 1

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