# DRW: Adaptor, Lead Switching, Electrocardiograph

- Device class: 2; regulation: 21 CFR 870.2350; FDA's rule: 510(k) required
- FDA decisions: 8
- 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)
- 1976: 1
- 1985: 2
- 1986: 1
- 1987: 1
- 1994: 1
- 2002: 1
- 2004: 1

## Most-cited predicates
- K033513: Easi Ecg Algorithm (2004), cited by 19
- K872781: Easi Lead System Cable Assembly (1987), cited by 2
- K020456: Easi 12 Lead Algorithm (2002), cited by 1
- K930786: EPCOR (1994), cited by 1

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