# K103567: Lifepak 15 Monitor/Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control, Inc.
- Decided: Mar 22, 2011 after 106 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
Longest line of descent: 10 generations back to K921669 (1993). 31 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082937: Lifepak 15 Monitor/Defibrillator, Physio-Control, Inc. (2009) Summary page 2.

## Most influential descendants
- K142430: LIFEPAK 15 monitor/defibrillator (2014), 2 descendants of its own
- K240162: LIFEPAK® 35 AC Power Adapter  (41335-000001) (2024), 1 descendant of its own
- K253099: LIFEPAK 15 AC Power Adapter (41577-000333) (2025), 0 descendants of its own
- K130454: Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor (2013), 0 descendants of its own

## Indications for use
Manual Defibrillation: Indications Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. Contraindications Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole. Automated External Defibrillation: Indications AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old. Noninvasive Pacing Indications Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.* Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole. 12-lead Electrocardiography: Indications The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST-elevation myocardial infarction (STEMVI). Pulse Oximetry Indications Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SP02 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusioh conditions. Noninvasive Blood Pressure Monitoring: Indications Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance. End-Tidal C02 monitoring: Indications EtCO 2.monitoring is used to detect trends in the level of expired 002. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. Invasive Pressure Monitoring: Indications Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis. Temperature Monitoring: Indications Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.

Source page: https://510kreport.com/device/K103567
Methodology: https://510kreport.com/methodology