# BTG: Brush, Biopsy, Bronchoscope (Non-Rigid)

- Device class: 2; regulation: 21 CFR 874.4680; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 49 days (middle half 49–49)
- Recalls: 2 (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)
- 1978: 1
- 1982: 1
- 2013: 1
- 2019: 1
- 2020: 1
- 2025: 1

## Most-cited predicates
- K190293: Single Use Cytology Brush BC-205D (2019), cited by 3
- K820771: Microbiology Specimen Brush (1982), cited by 1
- K780872: Cytology Brush (1978), cited by 1

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