# DTC: Analyzer, Pacemaker Generator Function

- Device class: 2; regulation: 21 CFR 870.3630; FDA's rule: 510(k) required
- FDA decisions: 30
- Recalls: 0 (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)
- 1986: 1
- 1988: 1
- 1989: 2
- 1990: 1
- 1991: 3
- 1996: 1
- 2000: 1
- 2001: 1
- 2009: 1
- 2017: 1

## Most-cited predicates
- K903966: External Pacemaker Analyzer Model Pma-1 (1991), cited by 2
- K884331: Medtronic Model 5311B a-V Pacing System Analyzer (1989), cited by 2
- K910595: Model 5311B a-V Pacing System Analyzer (1991), cited by 2
- K961582: External Pacemaker Analyzer, Model PMT 100 (1996), cited by 1
- K083674: PK-141 Patient Cable (2009), cited by 1

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