# NSA: Over-The-Counter Automated External Defibrillator

- Device class: 3; regulation: 21 CFR 870.5310; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 2 (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)
- 2004: 1
- 2019: 2
- 2020: 4
- 2021: 6
- 2022: 5
- 2023: 4
- 2024: 4
- 2025: 2
- 2026: 1

## Most-cited predicates
- K040904: Philips Heartstart Home Defibrillator, Model M5068A (2004), cited by 2

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