# DRO: Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

- Device class: 2; regulation: 21 CFR 870.5550; FDA's rule: 510(k) required
- FDA decisions: 84
- Recalls: 17 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1991: 3
- 1992: 3
- 1993: 1
- 1995: 3
- 1996: 1
- 1997: 2
- 1998: 1
- 1999: 2
- 2000: 1
- 2001: 2

## Most-cited predicates
- K951593: Lifepak 11 (1995), cited by 2
- K883375: Model #918 Multi-Pads (1988), cited by 1
- K854196: Dci Model EP-2 Clinical Stimulator (1986), cited by 1
- K914955: K-Defib/Pace Electrode (1992), cited by 1
- K950483: Hewlett Packard M2475B Codemaster 100 Defibrillator/Monitor (1995), cited by 1
- K961138: Esort II + 400 Series Monitor (1996), cited by 1

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