# FDX: Endoscopic Cytology Brush

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 44
- 510(k) review time 2021–2025: median 231 days (middle half 215–246)
- 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)
- 2002: 1
- 2004: 1
- 2005: 1
- 2010: 1
- 2015: 1
- 2017: 2
- 2018: 1
- 2019: 4
- 2022: 1
- 2025: 1

## Most-cited predicates
- K896318: Wilson-Cook Cytology Brushes (1990), cited by 3
- K171573: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (2017), cited by 2
- K040324: Wilson-Cook Double Lumen Biliary Cytology Brush (2004), cited by 2
- K770913: Urological Biopsy Brush Set (1977), cited by 2
- K172663: Cytology Brush (2018), cited by 1
- K181317: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (2019), cited by 1
- K192908: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (2019), cited by 1
- K103437: US Endoscopy Cytology Brush (2010), cited by 1
- K834402: Gastrointestinal Sheath Brush (1984), cited by 1

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