# K081442: Heart Sync Pediatric, Model Ped-100

- Pathway: 510(k) (Traditional)
- Applicant: Heart Sync, LLC
- Decided: Sep 24, 2008 after 125 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: 2 generations back to K002280 (2001). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020288: Padpro, Model 2603, Padpro, LLC (2002) Summary page 1.

## Most influential descendants
- K120536: Heart Sync Pediatric Physio Aed Pad (2012), 0 descendants of its own
- K103783: Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric (2011), 0 descendants of its own

## Indications for use
The Heart Sync Pediatric Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on pediatric patients whose weight is less than 25 kg. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.

Source page: https://510kreport.com/device/K081442
Methodology: https://510kreport.com/methodology