# K040775: Lifepak 12

- Pathway: 510(k) (Special)
- Applicant: Medtronic Physio-Control Corp.
- Decided: Apr 23, 2004 after 28 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: 6 generations back to K921669 (1993). 27 ancestors in all.
10 later devices descend from it; 5 cite it directly.
2 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033275: Lifepak 12, 20, 500, CR Plus, Medtronic Physio-Control Corp. (2003) Summary page 1.
- K010918: Lifepak 12 Defibrillator/Monitor System, Medtronic Physio-Control Corp. (2001) Summary page 1.
- K002445: Lifepak 12DEFIBERLLATOR/Monitor Series, Medtronic Physio-Control Corp. (2001) Summary page 1.
- K990338: Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor System, Physio-Control Corp. (1999) Summary page 1.
- K991910: Lifepak 12 Biphasic, Physio-Control Corp. (1999) Summary page 1.
- K973486: Life Pak 12, Physio-Control Corp. (1998) Summary page 1.

## Most influential descendants
- K041459: Lifepak 12 Defibrillator/Monitor (2004), 9 descendants of its own
- K063510: Lifepak 12 Defibrillator/Monitor (2007), 7 descendants of its own
- K082937: Lifepak 15 Monitor/Defibrillator (2009), 5 descendants of its own
- K103567: Lifepak 15 Monitor/Defibrillator (2011), 4 descendants of its own
- K142430: LIFEPAK 15 monitor/defibrillator (2014), 2 descendants of its own

## Recalls of this device
- Jan 15, 2005 · Not classified · Z-0495-05: The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.

## Indications for use
AEF) mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless. and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old. Manual D)elibrillation is indicated for the termination of certain potentially fat3al arrhythmias, such as ventricular fibrillation and symptornatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole. 12-Lead ElectrocardiopraphN, Y is useful in the early detection and prompt treatment of patients with acute myocardial infarction. Pulse Oxinmetry is used ito check the saturation of oxygen in arterial blood. It is indicated for use in any p:1iient who is ai risk of developing hypoxemia. Noninvasive Blood Pressure MonitorinLt is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis. End-Tidal C02 monitoring is indicated for detection of trends in the level of expired C02. It is used for monitoring breathing efficacy 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 is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.

Source page: https://510kreport.com/device/K040775
Methodology: https://510kreport.com/methodology