# K020203: Padpro Model #2516

- Pathway: 510(k) (Special)
- Applicant: Padpro, LLC
- Decided: May 8, 2002 after 106 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981737 (1998). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981737: K-Defib/Pace Adult Electrode Model Number KDP-60, Katecho, Inc. (1998) Summary page 1.

## Most influential descendants
- K080421: Heart Sync, Models C-100 and T-100 (2008), 4 descendants of its own
- K131550: Heart Sync (2013), 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
- K103334: Cardio Med (2011), 0 descendants of its own
- K103159: Cardio Med Model A102, H104, O101, P103, and Z100 (2011), 0 descendants of its own

## Recalls of this device
- Nov 6, 2014 · Class I · Z-0457-2015: 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
- Nov 6, 2014 · Class I · Z-0458-2015: 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
- Mar 8, 2007 · Not classified · Z-0757-2007: Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connector
- Mar 8, 2007 · Not classified · Z-0756-2007: Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connector

## Indications for use
The PadPro non-radiotransparent (radiotranslucent with minor shadowing) external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent 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 adult patients. When a patient requires defibrillation, cardioversiofi-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).

Source page: https://510kreport.com/device/K020203
Methodology: https://510kreport.com/methodology