# K103159: Cardio Med Model A102, H104, O101, P103, and Z100

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Medical Products, Inc.
- Decided: Jan 11, 2011 after 77 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981737 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080421: Heart Sync, Models C-100 and T-100, Heart Sync, LLC (2008) Summary page 1.
- 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.

## Recalls of this device
- Apr 26, 2013 · Class II · Z-1669-2013: Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.

## Indications for use
The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG 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 Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIOCONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.

Source page: https://510kreport.com/device/K103159
Methodology: https://510kreport.com/methodology