# K970719: 700-MP Disposable Radiolucent Multi-Pad Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Cardiotronics Systems, Inc.
- Decided: Apr 16, 1997 after 48 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) R2 Medical Systems 600 Series electrode: named in the summary without a submission number
- (no number) Cardiotronics Systems #918 Multi-pad Electrodes: named in the summary without a submission number

## Indications for use
The 700-MP Series Radiolucent Multi-pad electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The MP designation refers to the multifunctionality of these electrodes wherein the separate ECG monitoring elements allow for continuous ECG monitoring through the attachment of separate ECG leadwires. The radiolucent substrate of these electrodes makes them particularly well suited for certain clinical applications involving radiographic viewing. The expected patient population for the use of these devices is primarily adults. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. Individual catalog numbers are labeled for more specific use based primarily on the interface connector and cable system which defines the host external device, such as an external defibrillator. The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labeled with one or more of the following intended uses: External Defibrillation External Pacing ECG Monitoring Synchonized Cardioversion As with all electrodes of this type, labeling indicates that separate ECG electrodes are required for monitoring during external pacing. In the case of 700-MP Radiolucent Multi-Pad Electrodes these separate ECG monitoring electrodes are provided on the same foam backing for the optional attachment of separate ECG leadwires.

Source page: https://510kreport.com/device/K970719
Methodology: https://510kreport.com/methodology