# K103783: Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric

- Pathway: 510(k) (Traditional)
- Applicant: Fiab Spa
- Decided: Jun 16, 2011 after 171 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981737 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
4 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080421: Heart Sync, Models C-100 and T-100, Heart Sync, LLC (2008) Summary page 1.
- K081442: Heart Sync Pediatric, Model Ped-100, Heart Sync, LLC (2008) Summary page 1.

## Indications for use
EURO DEFI PADS series of disposable multi-function electrodes are indicated for the following clinical applications: - external defibrillation - synchronized cardioversion - cardiac stimulation - ECG monitoring EURO DEFI PADS series of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin. These devices are available with different connectors compatible for use with different defibrillators. All devices are non-sterile and for single-use only. The pediatric model of EURO DELI PADS disposable multi-function electrodes is intended for use on pediatric patient under eight years of age, or weighting less than 25 kg, the device is designed to deliver a maximum of 100 joule. The adult model of EURO DEFI PADS disposable multi-function electrodes is intended for use on adult patients and children older than eight years or greater than 25 kg, the device is designed to deliver a maximum of 360 joule. The radio-transparent adult model EURO DEFI PADS disposable multi-function electrodes for adult patient use only, is well suited for certain clinical applications involving radiographic viewing.

Source page: https://510kreport.com/device/K103783
Methodology: https://510kreport.com/methodology