# DRL: Tester, Defibrillator

- Device class: 2; regulation: 21 CFR 870.5325; FDA's rule: 510(k) required
- FDA decisions: 19
- Recalls: 1 (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)
- 1995: 1
- 1996: 1
- 1997: 1
- 2003: 1
- 2007: 1
- 2008: 2
- 2011: 1
- 2015: 1
- 2018: 1
- 2019: 1

## Most-cited predicates
- K941404: Impulse 4000 Defibrillator/Transcutaneous Pacer Analyzer (1994), cited by 2
- K904159: Defibrillator Analyzer Model Qed-5 (1991), cited by 1
- K896985: Zap-Guard (1990), cited by 1
- K790394: Defibrillator Interal Paddle Test Load (1979), cited by 1
- K083347: Impulse 7010 Defibrillator Selectable Loads (2008), cited by 1
- K963190: QA-40M Defibrillator Tester (1997), cited by 1
- K110192: Defibrillator Analyzer - DA-2006P (2011), cited by 1
- K072114: Impulse 6000D/7000DP (2008), cited by 1

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