# K080421: Heart Sync, Models C-100 and T-100

- Pathway: 510(k) (Traditional)
- Applicant: Heart Sync, LLC
- Decided: Feb 29, 2008 after 14 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 11 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981737 (1998). 2 ancestors in all.
4 later devices descend from it; 4 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)
- K020203: Padpro Model #2516, Padpro, LLC (2002) Summary page 1.
- K981737: K-Defib/Pace Adult Electrode Model Number KDP-60, Katecho, Inc. (1998) Summary page 1.

## Most influential descendants
- 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 11, 2014 · Class I · Z-0584-2015: Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp 
- Nov 11, 2014 · Class I · Z-0585-2015: Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp 
- Nov 11, 2014 · Class I · Z-0583-2015: Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp 
- Nov 11, 2014 · Class I · Z-0586-2015: Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp 
- Nov 11, 2014 · Class I · Z-0587-2015: Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp 
- Apr 26, 2013 · Class II · Z-1434-2013: On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment fr
- Apr 26, 2013 · Class II · Z-1435-2013: On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment fr
- Dec 17, 2010 · Not classified · Z-1372-2011: The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to 
- Dec 17, 2010 · Not classified · Z-1371-2011: The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to 
- Dec 5, 2008 · Not classified · Z-1950-2011: The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
- Dec 5, 2008 · Not classified · Z-1951-2011: The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.

## Indications for use
The Heart Sync Adult Radio Transparent Multi Function Electrodes and Heart Sync Adult 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 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). 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/K080421
Methodology: https://510kreport.com/methodology