# GKL: Counter, Cell, Automated (Particle Counter)

- Device class: 2; regulation: 21 CFR 864.5200; FDA's rule: 510(k) required
- FDA decisions: 130
- Recalls: 8 (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)
- 1997: 2
- 1998: 2
- 1999: 1
- 2000: 1
- 2002: 1
- 2004: 1
- 2005: 2
- 2007: 1
- 2010: 1
- 2016: 1

## Most-cited predicates
- K962988: Coulter Gen-S System (1996), cited by 3
- K920719: Ivos Analyzer (1992), cited by 3
- K912494: Sysmex (TM) R-3000 Automated Reticulocyte Analyzer (1991), cited by 3
- K971998: Advia 120 Hematology System, in Vitro Diagnostic System (1997), cited by 3
- K872166: Facscan Flow Cytometer - Reticcount Reti. Enu. Kit (1987), cited by 3
- K880636: Reticcount Software (1988), cited by 2
- K964375: Sysmex SE/Ram-1 (1997), cited by 2
- K091539: IQ 200 Urine Analizer Body Fluids Module (2010), cited by 1
- K952308: Coulter Z 1 (1995), cited by 1
- K870603: System 9000 Automated Cell Counter (1987), cited by 1

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