# HED: Douche Apparatus, Vaginal, Therapeutic

- Device class: 1; regulation: 21 CFR 884.5900; FDA's rule: 510(k) exempt
- FDA decisions: 12
- 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)
- 1978: 1
- 1980: 3
- 1983: 1
- 1984: 1
- 1986: 1
- 1988: 1
- 1990: 1
- 2000: 1
- 2003: 1
- 2008: 1

## Most-cited predicates
- K000736: LA Joie (2000), cited by 1
- K902830: Peri-Bottle (1990), cited by 1

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