# LPA: System, Esophageal Pacing

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 3 (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)
- 1992: 1
- 1994: 1
- 1997: 2
- 1998: 2
- 2004: 3
- 2005: 2
- 2009: 1
- 2012: 3
- 2016: 1
- 2017: 1

## Most-cited predicates

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