# LKB: Pad, Alcohol, Device Disinfectant

- Device class: U; regulation: 21 CFR —
- FDA decisions: 25
- Recalls: 5 (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)
- 1984: 2
- 1985: 1
- 1986: 1
- 1987: 1
- 1989: 5
- 1990: 2
- 1991: 3
- 2012: 1
- 2013: 1
- 2014: 1

## Most-cited predicates
- K833182: Aplicare Alcohol Prep Pad (1983), cited by 3
- K112791: Sitescrub Ipa Device (2012), cited by 2
- K121655: BD Alcohol Swab (2013), cited by 1

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