# DTE: Pulse-Generator, Pacemaker, External

- Device class: 2; regulation: 21 CFR 870.3600; FDA's rule: 510(k) required
- FDA decisions: 65
- 510(k) review time 2021–2025: median 164 days (middle half 144–184)
- 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)
- 2003: 2
- 2004: 1
- 2013: 2
- 2015: 1
- 2016: 2
- 2018: 2
- 2019: 2
- 2020: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K964190: Era 300 Dual Chamber Pacing System Analyzer (1997), cited by 5
- K923621: External Demand Pacemaker (1993), cited by 3
- K970497: PACE 101H (1997), cited by 3
- K020896: Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene (2002), cited by 2
- K132924: Medtronic External Pulse Generator (Epg) (2013), cited by 2
- K960676: Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004 (1996), cited by 1
- K150246: Medtronic Model 5392 External Pulse Generator (EPG) (2015), cited by 1
- K910237: Modified Model 5330 AV Demand Pulse Generator (1991), cited by 1
- K182839: Lifetech Cardio Model 8301 Temporary Pacemaker (2019), cited by 1
- K971474: Medtronic Model 5318 Temporary Pacemaker/Implant Tool (1997), cited by 1

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