# K020288: Padpro, Model 2603

- Pathway: 510(k) (Special)
- Applicant: Padpro, LLC
- Decided: Feb 27, 2002 after 30 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002280 (2001). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K002280: Pad Pro Pediatric Electrode, Model Pad Pro 2602, Medical Devices, Inc. (2001) Summary page 1.

## Most influential descendants
- K081442: Heart Sync Pediatric, Model Ped-100 (2008), 2 descendants of its own
- 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

## Recalls of this device
- Nov 6, 2014 · Class I · Z-0459-2015: Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of thera

## Indications for use
The PadPro pediatric electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use only. The PadPro 2603 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patient’s skin. The electrode is intended for use on pediatric patients whose weight is less than 10kg (22 Ibs). 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 can be limited to 30 joules maximum. The PadPro 2603 pediatric electrodes are designed for, and to be used with the Physio-control, Zoll, and Hewlett Packard defibrillators.

Source page: https://510kreport.com/device/K020288
Methodology: https://510kreport.com/methodology