# LDM: Instrumentation, High Pressure Liquid Chromatography

- Device class: 1; regulation: 21 CFR 862.2260; FDA's rule: 510(k) exempt
- FDA decisions: 19
- Recalls: 1 (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)
- 1982: 2
- 1983: 2
- 1985: 2
- 1986: 1
- 1987: 2
- 1989: 1
- 1990: 1
- 1992: 2
- 1994: 1
- 1996: 2

## Most-cited predicates
- K833113: Reporting Integrator 3392A (1983), cited by 1
- K942451: Bio-Rad Clinical Data Management System (1994), cited by 1

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