# LED: Stains, Chemical Solution

- Device class: 1; regulation: 21 CFR 864.1850; FDA's rule: 510(k) exempt
- FDA decisions: 16
- 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)
- 1981: 1
- 1983: 2
- 1984: 3
- 1985: 2
- 1986: 6
- 2002: 1
- 2005: 1

## Most-cited predicates
- K051409: Slivasure (2005), cited by 1
- K023046: SST Saliva Supporting Tablets (2002), cited by 1

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