# ILS: Adaptor, Hygiene

- Device class: 1; regulation: 21 CFR 890.5050; FDA's rule: 510(k) exempt
- FDA decisions: 31
- 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)
- 1976: 5
- 1978: 2
- 1979: 4
- 1980: 1
- 1981: 4
- 1982: 8
- 1983: 5
- 1984: 1
- 1985: 1

## Most-cited predicates
- K821860: BK-6477 the Derby Raised Toilet Seat (1982), cited by 1

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