# LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)

- Device class: 2; regulation: 21 CFR 870.5300; FDA's rule: 510(k) required
- FDA decisions: 166
- 510(k) review time 2021–2025: median 70 days (middle half 70–70)
- Recalls: 28 (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)
- 2003: 2
- 2004: 1
- 2008: 2
- 2010: 2
- 2011: 4
- 2014: 1
- 2015: 1
- 2019: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker (2002), cited by 4
- K914971: Tec-8251A Defibrillator Monitor, Modification (1991), cited by 2
- K100654: Zoll Propaq MD (2010), cited by 2
- K935674: Lifepak 9 Defibrillator/Monitor (1993), cited by 2
- K863405: Cardiolife Tec 7200 (1986), cited by 2
- K081442: Heart Sync Pediatric, Model Ped-100 (2008), cited by 2
- K930548: DPD Defibrillator (1993), cited by 1
- K931053: Lifepak 10 Defibrillator/Monitor W/Opt Pacemaker (1993), cited by 1
- K940842: Unipower Rechargeable Battery Pack (1994), cited by 1
- K800937: R2 Plate Type Cable-Adaptor #S 175,176 (1980), cited by 1

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