# K051632: Philips Heartstart FR2+ Automated External Defibrillator, Models M3860A, M3861A, M3840A, M3841A

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Oct 5, 2005 after 107 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 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) Philips/Heartstream HeartStart FR2+ AED: named in the summary without a submission number

## Most influential descendants
- K072923: Zoll E Series Defibrillator (2008), 10 descendants of its own
- K112432: Zoll X Series (2012), 8 descendants of its own
- K133269: Zoll X Series (2014), 4 descendants of its own
- K121367: Zoll Propaq XM (2012), 3 descendants of its own
- K180482: ZOLL Propaq M (2018), 2 descendants of its own

## Recalls of this device
- Feb 9, 2021 · Class II · Z-0078-2022: Customers were not notified of previous recalls associated with various defibrillator models.
- 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.
- Oct 1, 2009 · Not classified · Z-0062-2010: A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
- Oct 1, 2009 · Not classified · Z-0063-2010: A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.

## Indications for use
The HeartStart FR2+ is intended to be used with disposable defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing. If in doubt, apply the pads. When the patient is under 8 years or weighs less than 55 pounds (25 kg), apply FR2 infant/child reduced-energy defibrillator pads, if available. WARNING: Performance of the SMART CPR AUTOl and AUTO2 settings has not been established in patients under 8 years or 55 lb (25 kg). See Appendix E for more information. The HeartStart 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 assessment module to display the rhythm of a responsive or breathing patient, regardless of age. The FR2+ and ECG assessment module system provides a non-diagnostic display for attended patient monitoring. While connected to the FR2+ ECG assessment module, the FR2+ evaluates the patient's ECG and disables its shock capability.

Source page: https://510kreport.com/device/K051632
Methodology: https://510kreport.com/methodology