# KLR: Enzyme Immunoassay, Lidocaine

- Device class: 2; regulation: 21 CFR 862.3555; FDA's rule: 510(k) required
- FDA decisions: 17
- 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)
- 1980: 2
- 1982: 1
- 1983: 7
- 1984: 1
- 1985: 1
- 1988: 1
- 1997: 1
- 2004: 2
- 2009: 1

## Most-cited predicates
- K033809: Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D (2004), cited by 5
- K853010: Cobas Reagent for Lidocaine & Calibrators (1985), cited by 1
- K833379: Lidocaine Analytical Test Pack Aca (1983), cited by 1

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