# HHW: Pessary, Vaginal

- Device class: 2; regulation: 21 CFR 884.3575; FDA's rule: 510(k) required
- FDA decisions: 41
- 510(k) review time 2021–2025: median 262 days (middle half 179–268)
- Recalls: 12 (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)
- 2010: 1
- 2013: 1
- 2014: 2
- 2015: 1
- 2016: 1
- 2018: 1
- 2019: 2
- 2024: 5
- 2025: 1
- 2026: 1

## Most-cited predicates
- K974116: Pelvx Incontinence Ring (1998), cited by 3
- K081385: Uresta Pessary (2008), cited by 3
- K930618: Vaginal Continence Device (1995), cited by 2
- K132313: Pessary (2014), cited by 2
- K993308: Mentor Evacare Vaginal Pessaries (1999), cited by 2
- K013289: Bioteque Vaginal Pessaries (2001), cited by 2
- K092981: Panpac Vaginal Pessary (2010), cited by 2
- K965040: Introl Bladder Neck Support Prosthesis with Removal Tool (1997), cited by 2
- K060526: TIPI (2006), cited by 1
- K920747: Pessary Flexible Silicone Donut Ring (1994), cited by 1

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