# K955628: Fore Runner External Defibrillator/Defibrillator Pads

- Pathway: 510(k) (Traditional)
- Applicant: Heartstream, Inc.
- Decided: Sep 10, 1996 after 274 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.
48 later devices descend from it; 7 cite it directly.
6 of 49 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) Zoll Medical Corporation Semi-Automatic External Defibrillator: named in the summary without a submission number
- (no number) SurVivaLink Corporation Vivalink Semi-Automatic External Defibrillator: named in the summary without a submission number
- (no number) Laerdal Medical Corporation Heartstart Semi-automatic External Defibrillator: named in the summary without a submission number
- (no number) Hewlett Packard Corporation Codemaster XL Defibrillator/Monitor: named in the summary without a submission number
- (no number) PhysioControl Corporation LifePak 100 External Defibrillator: named in the summary without a submission number
- (no number) W. Kouwenhoven, M.D. Biphasic External Defibrillator (Johns Hopkins Hospital): named in the summary without a submission number
- (no number) Mine Safety Appliance Company Biphasic External Defibrillator: named in the summary without a submission number
- (no number) Katecho, Inc. External Pacing and Defibrillation electrodes: named in the summary without a submission number
- (no number) Zoll Medical Corporation Multi-function electrodes: named in the summary without a submission number
- (no number) SurVivaLink Corporation Defibrillation electrodes: named in the summary without a submission number

## Most influential descendants
- K983393: Lifepak 500 Biphasic (1999), 25 descendants of its own
- K991910: Lifepak 12 Biphasic (1999), 22 descendants of its own
- K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker (2002), 21 descendants of its own
- K012428: Modification to: Lifepak 500 Automated External Defibrillator (2001), 21 descendants of its own
- K033275: Lifepak 12, 20, 500, CR Plus (2003), 20 descendants of its own

## Indications for use
The ForeRunner external defibrillator, is indicated for use on victims of sudden cardiac arrest on whom an apparent lack of circulation is indicated by unconsciousness, absence of breathing and absence of detectable pulse.

Source page: https://510kreport.com/device/K955628
Methodology: https://510kreport.com/methodology