# HDX: Dilator, Vaginal

- Device class: 2; regulation: 21 CFR 884.3900; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 164 days (middle half 83–277)
- Recalls: 0 (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)
- 2001: 1
- 2009: 1
- 2013: 1
- 2021: 1
- 2023: 3
- 2024: 2

## Most-cited predicates
- K130273: Panpac Vaginal Dilators (2013), cited by 2
- K211959: Milli Vaginal Dilator (2021), cited by 1
- K003380: Bioteque Vaginal Dilator (2001), cited by 1
- K220035: Milli Vaginal Dilator (2023), cited by 1

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