# LDF: Electrode, Pacemaker, Temporary

- Device class: 2; regulation: 21 CFR 870.3680; FDA's rule: 510(k) required
- FDA decisions: 129
- 510(k) review time 2021–2025: median 267 days (middle half 164–268)
- Recalls: 8 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2008: 1
- 2014: 1
- 2015: 2
- 2016: 3
- 2017: 1
- 2018: 1
- 2019: 1
- 2024: 1
- 2025: 5
- 2026: 1

## Most-cited predicates
- K040812: Detect Surgical Pacing and Mapping Tool (2004), cited by 4
- K012459: Model 6494 Unipolar Temporary Myocardial Pacing Wire (2001), cited by 3
- K800298: Usci Bipolar Ballon Pacing Electrode (1980), cited by 2
- K850622: Oscor Medical Model Tme 64S Bipolar Temp/Heart Wir (1985), cited by 2
- K980503: Temporary Cardiac Pacing Wire (1998), cited by 2
- K944957: Temporary Myocardial Pacing Lead, Model 6500 (1995), cited by 2
- K930069: Bipolar Balloon Pacing Catheter by J-Lloyd (1994), cited by 2
- K032613: Temporary Transvenous Pacemaker Placement Assist Device (2003), cited by 2
- K171253: Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead (2017), cited by 2
- K140972: Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead, Unipolar Temporary Myocardial Pacing (2014), cited by 2

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