# K964469: 700-F Series Stimulation Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Cardiotronics Systems, Inc.
- Decided: Dec 11, 1996 after 34 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.
- (no number) R2 Medical Systems 600 Series electrode: named in the summary without a submission number

## Most influential descendants
- K150349: Rapid Hair Removal Pads (2015), 0 descendants of its own

## Recalls of this device
- Nov 6, 2014 · Class I · Z-0461-2015: 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-0462-2015: 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
- Mar 31, 2011 · Not classified · Z-0856-2012: The specific lot was assembled without the rivet cover.
- Mar 9, 2011 · Not classified · Z-0735-2012: The product lot was assembled with an R2 Connector, rather than a Zoll Connector.

## Indications for use
The 700-F series elecirodes are disposable electrodes for extemnal cardiac stimulation and monitoring. Electrodes of this design are suitable for extermal pacing, external defibrillation, synchronized cardloversion and ECG monitoring. The expected patient population for the use of these devices includes adults and children. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. The duration for use is intended to be less than 24 hours. 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

Source page: https://510kreport.com/device/K964469
Methodology: https://510kreport.com/methodology