# LRJ: Disinfectant, Medical Devices

- Device class: 1; regulation: 21 CFR 880.6890; FDA's rule: 510(k) exempt
- FDA decisions: 73
- Recalls: 10 (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)
- 1987: 2
- 1989: 1
- 1992: 4
- 1993: 1
- 1994: 10
- 1995: 28
- 1996: 15
- 1997: 2
- 1998: 7
- 1999: 3

## Most-cited predicates
- K923744: Cidex Plus 28 Day Solution (1994), cited by 3
- K924434: Cidex Activated Dialdehyde Solution (1994), cited by 3
- K882564: Renalin Cold Sterilant (1989), cited by 1

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