# DTA: Tester, Pacemaker Electrode Function

- Device class: 2; regulation: 21 CFR 870.3720; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 2 (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)
- 1981: 1
- 1993: 1
- 2000: 1
- 2001: 2
- 2002: 6
- 2003: 4
- 2005: 1
- 2007: 1
- 2010: 1
- 2017: 1

## Most-cited predicates
- K022360: Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); NK-11 Power Supp. (2003), cited by 3
- K033613: Modification to Era 300 Dual Chamber Pacing System Analyzer (2003), cited by 1

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