# DTD: Pacemaker Lead Adaptor

- Device class: 2; regulation: 21 CFR 870.3620; FDA's rule: 510(k) required
- FDA decisions: 103
- 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)
- 1994: 2
- 1995: 1
- 1997: 3
- 1998: 1
- 2000: 1
- 2001: 2
- 2003: 2
- 2004: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K911302: Models 5866-24M/5866-38M/5866-40M/6986M Adapt Kit (1991), cited by 2
- K902889: A1-a,A1-B,A1-Abp,A1-MBP,A1-Z,A6-a,A6-B,Peh Pace. (1990), cited by 1
- K911827: Model 5866-9M & Model 6981M (1991), cited by 1
- K915724: Model 6984M Lead Extender Kit (1992), cited by 1
- K841451: Biotronik DY-Unipolar (1985), cited by 1
- K843060: Sentra (1984), cited by 1

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