# K014157: HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Jan 17, 2002 after 29 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
1 of 10 devices in its family (counting itself) has 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) Medtronic/Physio-Control LifePak 500: named in the summary without a submission number

## Most influential descendants
- K040637: Powerheart Aed G3 Pro (2004), 3 descendants of its own
- K111693: Philips Heartstart FR3 Automated External Defibrillator (2011), 2 descendants of its own
- K102496: Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 Plus (2011), 2 descendants of its own
- K122758: Powerheart G5 Aed (2014), 1 descendant of its own
- K042404: Lifepak, Model 1000 (2005), 1 descendant of its own

## Recalls of this device
- 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 Heartstream FR2 is indicated for use on persons experiencing the symptoms of sudden cardiac arrest: Lack of responsiveness Lack 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. DO NOT DELAY TREATMENT TO DETERMINE THE CHILD’S EXACT AGE/WEIGHT. The Heartstream 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, advanced life support, or other physician-authorized emergency medical response.

Source page: https://510kreport.com/device/K014157
Methodology: https://510kreport.com/methodology