# K002280: Pad Pro Pediatric Electrode, Model Pad Pro 2602

- Pathway: 510(k) (Traditional)
- Applicant: Medical Devices, Inc.
- Decided: Feb 5, 2001 after 194 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020288: Padpro, Model 2603 (2002), 3 descendants of its own
- 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
- Feb 23, 2018 · Class II · Z-1178-2018: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- Feb 23, 2018 · Class II · Z-1176-2018: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- Feb 23, 2018 · Class II · Z-1177-2018: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- Feb 23, 2018 · Class II · Z-1175-2018: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- Feb 23, 2018 · Class II · Z-1174-2018: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- Nov 6, 2014 · Class I · Z-0460-2015: 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

Source page: https://510kreport.com/device/K002280
Methodology: https://510kreport.com/methodology