# DXY: Implantable Pacemaker Pulse-Generator

- Device class: 3; regulation: 21 CFR 870.3610; FDA's rule: PMA required
- FDA decisions: 471
- Recalls: 72 (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)
- 2017: 51
- 2018: 45
- 2019: 19
- 2020: 23
- 2021: 20
- 2022: 14
- 2023: 19
- 2024: 20
- 2025: 19
- 2026: 19

## Most-cited predicates
- K914109: Pikos 01 & Pikos E 01 (1992), cited by 2
- K882391: Opus 3 Pulse Generators Models 4003,4004,4023,4024 (1988), cited by 1
- K952364: Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024) (1995), cited by 1
- K900461: Opus Model 4021, Vvi, 5MM Unipolar (1990), cited by 1
- K813101: Cardiobeeper Memory Monitor (1981), cited by 1
- K911122: 8MM Quantum Pulse/Suprima II Pulse Generators (1991), cited by 1
- K923026: Pikos 01-a and Pikos E01-a Implantable Pacemaker (1993), cited by 1

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