# MKJ: Automated External Defibrillators (Non-Wearable)

- Device class: 3; regulation: 21 CFR 870.5310; FDA's rule: PMA required
- FDA decisions: 245
- Recalls: 239 (23 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 4
- 2018: 20
- 2019: 25
- 2020: 52
- 2021: 41
- 2022: 19
- 2023: 24
- 2024: 27
- 2025: 48
- 2026: 31

## Most-cited predicates
- K033275: Lifepak 12, 20, 500, CR Plus (2003), cited by 10
- K042007: Zoll E Series Defibrillator (2005), cited by 9
- K013425: Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A (2002), cited by 9
- K991910: Lifepak 12 Biphasic (1999), cited by 8
- K973486: Life Pak 12 (1998), cited by 8
- K955628: Fore Runner External Defibrillator/Defibrillator Pads (1996), cited by 7
- K020715: Philips M5066A and M5068A (2002), cited by 7
- K010918: Lifepak 12 Defibrillator/Monitor System (2001), cited by 7
- K002445: Lifepak 12DEFIBERLLATOR/Monitor Series (2001), cited by 6
- K981737: K-Defib/Pace Adult Electrode Model Number KDP-60 (1998), cited by 6

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