# K972418: Heartstramelectrode Adapter (EA-XX Series)/Heartstram Defibrillation Pads with Preattached Electrode Adapter (DP-Eaxx)

- Pathway: 510(k) (Traditional)
- Applicant: Heartstream, Inc.
- Decided: Sep 25, 1997 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Heartstream External Defibrillation Pads: named in the summary without a submission number
- (no number) K-Defib/Pace Multifunction Electrodes: named in the summary without a submission number
- (no number) Darox R2 series of adapter cables: named in the summary without a submission number

## Most influential descendants
- K033144: Defibtech Electrode Adapter, Model Dac-300 Series (2003), 0 descendants of its own

## Indications for use
Heartstream Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing. Heartstream External Defibrillation Pads with Preattached Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.

Source page: https://510kreport.com/device/K972418
Methodology: https://510kreport.com/methodology