# LRS: I.V. Start Kit

- Device class: 2; regulation: 21 CFR 880.5200
- FDA decisions: 30
- Recalls: 127 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1986: 2
- 1987: 2
- 1988: 1
- 1992: 1
- 1993: 9
- 1994: 5
- 1995: 2
- 1996: 1
- 2001: 1
- 2005: 1

## Most-cited predicates

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