# JOY: Device, Automated Cell-Locating

- Device class: 2; regulation: 21 CFR 864.5260; FDA's rule: 510(k) required
- FDA decisions: 35
- 510(k) review time 2021–2025: median 270 days (middle half 195–386)
- 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)
- 2008: 1
- 2009: 1
- 2010: 1
- 2011: 1
- 2017: 1
- 2018: 1
- 2020: 2
- 2022: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K040591: Duet System (2004), cited by 6
- K925670: IMS-200 (1993), cited by 5
- K050840: Modification to Duet System (2005), cited by 5
- K033840: Cellavision DM96 Automatic Hematology Analyzer (2004), cited by 4
- K030192: Duet System (2003), cited by 4
- K092868: Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127 (2009), cited by 3
- K061602: Duet System (2007), cited by 3
- K201301: X100 with Full Field Peripheral Blood Smear (PBS) Application (2020), cited by 2
- K052577: Ikoniscope Fastfish Amnio Imaging System (2006), cited by 2
- K001420: Slidescan (2000), cited by 1

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