# HDY: Dilator, Cervical, Hygroscopic-Laminaria

- Device class: 2; regulation: 21 CFR 884.4260; FDA's rule: 510(k) required
- FDA decisions: 11
- 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)
- 1979: 1
- 1984: 1
- 1985: 1
- 1988: 3
- 1989: 1
- 1996: 1
- 2001: 1
- 2002: 1
- 2005: 1

## Most-cited predicates
- K880196: Laminaria (1988), cited by 1
- K040625: Atad Ard Catheter (2005), cited by 1
- K021012: Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM (2002), cited by 1

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