# HDW: Diaphragm, Contraceptive (And Accessories)

- Device class: 2; regulation: 21 CFR 884.5350; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 1980: 1
- 2008: 2
- 2014: 1

## Most-cited predicates
- K063223: Milex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal Diaphragms (2008), cited by 1
- K080040: Ortho All-Flex Diaphragm (2008), cited by 1

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