# HFE: Brush, Endometrial

- Device class: 2; regulation: 21 CFR 884.1100; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 163 days (middle half 163–163)
- 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)
- 1985: 1
- 1988: 1
- 1990: 1
- 1994: 1
- 1995: 1
- 2008: 1
- 2012: 1
- 2017: 1
- 2024: 1

## Most-cited predicates
- K082066: Tao Brush I.U.M.C. Endometrial Sampler (2008), cited by 3
- K170603: Tao Brush I.U.M.C. Endometrial Sampler (2017), cited by 1
- K941298: Iumc Endometrial Sampler (1995), cited by 1

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