# K130684: Philips Heartstart FR3 Automated External Defibrillator - Pathway: 510(k) (Traditional) - Applicant: Philips Medical Systems - Decided: Oct 18, 2013 after 219 days - Product code: MKJ (Automated External Defibrillators (Non-Wearable)) - Device class: 3 - Regulation: 21 CFR 870.5310 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K020715 (2002). 12 ancestors in all. No later device cites it as a predicate yet. 1 of 13 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K111693: Philips Heartstart FR3 Automated External Defibrillator, Philips Medical Systems (2011) Summary page 4. - K013425: Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A, Philips Medical Systems (2002) - K014157: HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A, Philips Medical Systems (2002) Summary page 2. - K122050: Cprmeter CPR Feedback Device, Laerdal Medical A/S (2012) Summary page 2. - K051134: Heartstart MRX with Q-CPR Option, Models M3535A or M3536A, Philips Medical Systems (2005) Summary page 2. ## Recalls of this device - Jan 29, 2018 · Class II · Z-0683-2018: Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent In ## Indications for use The FR3 is intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The FR3 is used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: * Unresponsiveness * Absence of normal breathing If in doubt, apply the pads. The FR3 is intended for adults and children over 55 lbs (25 kg) or 8 years old. The FR3 is also intended for children under 55 lbs (25 kg) or 8 years old when used with the optional FR3 Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator. The FR3 is intended for use by responders who have been trained in its operation and qualified by training in Basic Life Support (BLS), Advanced Life Support (ALS), or another physic ian-authorized emergency medical response program. The FR3 can be configured under the guidance of a Medical Director to enable Advanced Use mode and alternative cardiopulmonary resuscitation (CPR) protocols, such as CPR while Armed, CPR First-User, and CPR First-Always. WARNING: Performance of the SMART CPR AUTO!I and AUTO2 settings for the CPR First feature has not been established in patients under 55 lb (25 kg) or 8 years old. CPR Meter with Q-CPR The FR3 can be used with the optional CPRI meter with Q-CPR® technology by Laerdal. The system is designed for application by a responder trained in its use. It serves as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old or 55 lb (25 kg). If the age or weight of the patient is in doubt, do not delay treatment. Perform CPR without using the CPR meter. WARNING: The CPR meter is not intended for use on SCA victims under 8 years old or 55 lb (25 kg). If the Infant/Child Key is installed in the FR3, the CPR meter is disabled. When attached to the bare chest of a suspected victim of SCA and connected to an 1113 used with compatible pads properly placed, the CPR meter provides real-time feedback on CPR in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, release, and rate of chest compressions. It also provides notification for lack of expected CPR activity and a stay-clear icon display during FR3 rhythm analysis and shock delivery. In addition, the FR3 alerts the responder when it detects hyperventilation (more than 12 ventilations per minute) of the patient during CPR. 3-Lead ECG Cable In addition, at the discretion of a responder trained in its use, the optional FR3 3-Lead ECG Cable can be connected to the FR3 ECG model to provide a non-diagnostic EG display of the heart rhythm of a patient who is responsive and breathing normally but at risk of cardiac distress. The system is intended for use on a conscious or breathing patient, regardless of age, for attended patient monitoring. The responder can select display of lead vectors 1,11, or 111. While connected to the 3-Lead Cable, the defibrillator's shock capability is disabled, but the FR3 continues to evaluate the patient's ECG. In addition, the 1113 alerts the responder to check the patient if the EGG indicates that the heart rate is less than 30 BPM or if the heart rhythm may benefit from a defibrillation shock. If the patient's rhythm or status changes, the responder can attend to the patient, as appropriate. FR3 Rechargeable Battery The FR3 rechargeable battery is intended for use by organizations, such as EMS or tire departments that use the FR3 frequently and want to decrease cost-per-use and reduce environmental waste. The rechargeable battery should only be used by organizations committed to providing the resources required to operate a battery maintenance program. Due to changes in the performance characteristics of rechargeable batteries over time, it is important for the battery maintenance program to monitor how many battery charge/discharge cycles the battery experiences, in order to determine when to retire it from service. The FR3 rechargeable battery is not recommended for infrequent-use environments such as office buildings, airlines, or public access defibrillation (PAD) programs. It should not be used as the spare or backup battery: instead, the standard primary battery should be used due to its long shelf-life. Source page: https://510kreport.com/device/K130684 Methodology: https://510kreport.com/methodology