# LRT: Indicator, Sterilization

- Device class: 2; regulation: 21 CFR 880.2800; FDA's rule: 510(k) required
- FDA decisions: 5
- 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)
- 1987: 1
- 1995: 1
- 1996: 1
- 1997: 1
- 2001: 1

## Most-cited predicates
- K002937: TST Control Integrator for Steam Sterilizers (2001), cited by 5
- K951113: Cross-Checks (1996), cited by 2
- K965154: TST Control Integrator for Steam Autoclave (1997), cited by 1

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