# K013425: Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jan 14, 2002 after 90 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
40 later devices descend from it; 9 cite it directly.
2 of 41 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 FR2 AED: named in the summary without a submission number
- (no number) Laerdal Heartstart 3000: named in the summary without a submission number
- (no number) Heartstream XLT Defibrillator/Monitor: named in the summary without a submission number
- (no number) Active Corporation ActiveECG device: named in the summary without a submission number

## Most influential descendants
- K041892: Zoll Aed Pro External Defibrillator (2005), 23 descendants of its own
- K060559: Zoll R Series Defibrillator (2006), 21 descendants of its own
- K100654: Zoll Propaq MD (2010), 11 descendants of its own
- K110742: Onestep Adult Multi-Function Electrode (2011), 9 descendants of its own
- K102468: Zoll Propaq MD (2010), 9 descendants of its own

## Recalls of this device
- Sep 22, 2010 · Not classified · Z-0487-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0483-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0485-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0486-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0488-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- Sep 22, 2010 · Not classified · Z-0484-2011: A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, 
- May 28, 2010 · Not classified · Z-0470-2011: Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
- May 28, 2010 · Not classified · Z-0472-2011: Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
- May 28, 2010 · Not classified · Z-0473-2011: Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.
- May 28, 2010 · Not classified · Z-0471-2011: Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.

## Indications for use
The FR2 is intended to be used with disposable Heartstream defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing. When the patient is under 8 years or weighs less than 55 pounds (25 kg), the FR2 should be used with attenuated pediatric defibrillation pads. The FR2 is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support (BLS), advanced life support (ALS) or other physician-authorized emergency medical response. At the discretion of emergency care personnel, the M3860A FR2 with ECG display enabled can also be used with the FR2 ECG Cable to display the rhythm of a responsive or breathing patient, regardless of age. The FR2 and ECG Cable system provides a non-diagnostic display for attended patient monitoring. While connected to the FR2 ECG Cable, the FR2 evaluates the patient’s ECG and disables it’s shock capability.

Source page: https://510kreport.com/device/K013425
Methodology: https://510kreport.com/methodology