# LKX: Device, Thermal, Hemorrhoids

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 18
- 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)
- 1988: 1
- 1991: 1
- 1992: 1
- 1995: 1
- 1998: 2
- 2001: 1
- 2005: 1
- 2008: 1
- 2012: 1
- 2018: 1

## Most-cited predicates
- K981428: Anu Ice (1998), cited by 3
- K042564: Hemor-Rite Cryotheraphy (2005), cited by 1
- K862490: ANU-RX (1986), cited by 1

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