# OSR: Pacemaker/Icd/Crt Non-Implanted Components

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 0
- Recalls: 11 (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)
- 2012: 1
- 2013: 2
- 2014: 8
- 2015: 8
- 2016: 3
- 2017: 1
- 2021: 2
- 2022: 1
- 2023: 3
- 2025: 2

## Most-cited predicates

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