# MLS: Labor And Delivery Kit

- Device class: 2; regulation: 21 CFR 884.4530
- FDA decisions: 6
- Recalls: 19 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1994: 4
- 1996: 2

## Most-cited predicates

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