# K014209: Padpro  Model 2001, 2001-S, 2001-C, 2001-Eps

- Pathway: 510(k) (Special)
- Applicant: Padpro, LLC
- Decided: Jan 18, 2002 after 28 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 4 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002806 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002806: K-Defib/Pace, Model KDP-60A, Katecho, Inc. (2000) Summary page 1.

## Most influential descendants
- K103186: Skintact Radiotransparent Multifunction Electrodes (2011), 0 descendants of its own
- K020743: Padpro, Model 2502 (2002), 0 descendants of its own

## Recalls of this device
- Nov 6, 2014 · Class I · Z-0455-2015: 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-0454-2015: 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-0456-2015: 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
- May 3, 2013 · Class II · Z-1317-2013: ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially rende

## Indications for use
The PadPro radiotransparent 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, 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).

Source page: https://510kreport.com/device/K014209
Methodology: https://510kreport.com/methodology