# JGS: Electrode, Ion Specific, Sodium

- Device class: 2; regulation: 21 CFR 862.1665; FDA's rule: 510(k) required
- FDA decisions: 162
- 510(k) review time 2021–2025: median 308 days (middle half 234–378)
- 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)
- 2014: 1
- 2015: 1
- 2016: 4
- 2017: 1
- 2018: 3
- 2019: 3
- 2020: 2
- 2022: 1
- 2023: 3
- 2026: 1

## Most-cited predicates
- K011213: Modification to Synchron LX 20 Clinical Chemistry System (2001), cited by 5
- K963627: (Modified Version) Integra Ion Selective Electrode (Ise) Module (1996), cited by 4
- K990346: Bayer Advia 1650 Chemistry System (1999), cited by 3
- K151767: Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator (2015), cited by 3
- K874832: Nova Stat Profile 5 Analyzer + Quality Control (1988), cited by 3
- K023049: Synchron LX I 725 Clinical System (2002), cited by 3
- K082462: Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+ (2009), cited by 2
- K161837: ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer (2016), cited by 2
- K061597: Epoc Blood Analysis System (2006), cited by 2
- K183688: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), cited by 2

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