# K102972: Lifepak 12

- Pathway: 510(k) (Special)
- Applicant: Physio-Control, Inc.
- Decided: Dec 22, 2010 after 77 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: 9 generations back to K921669 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063510: Lifepak 12 Defibrillator/Monitor, Medtronic Emergency Response Systems, Inc. (2007) Summary page 2.
- K041459: Lifepak 12 Defibrillator/Monitor, Medtronic Emergency Response Systems, Inc. (2004) Summary page 2.
- K040775: Lifepak 12, Medtronic Physio-Control Corp. (2004) Summary page 2.
- K033275: Lifepak 12, 20, 500, CR Plus, Medtronic Physio-Control Corp. (2003) Summary page 2.
- K010918: Lifepak 12 Defibrillator/Monitor System, Medtronic Physio-Control Corp. (2001) Summary page 2.
- K002445: Lifepak 12DEFIBERLLATOR/Monitor Series, Medtronic Physio-Control Corp. (2001) Summary page 2.
- K990338: Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor System, Physio-Control Corp. (1999) Summary page 2.
- K991910: Lifepak 12 Biphasic, Physio-Control Corp. (1999) Summary page 2.
- K973486: Life Pak 12, Physio-Control Corp. (1998) Summary page 2.

## Recalls of this device
- Jan 16, 2017 · Class II · Z-1143-2017: The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.

## Indications for use
Manual Defibrillation: Indications Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic 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. 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 12 defibrillator/monitor 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 myocardial infarction. Pulse Oximetry Indications Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia. Noninvasive Blood Pressure Monitoring: Indications Noninvasive blood pressure monitoring 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 CO2 monitoring: Indications EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. 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. It is intended for use on adult and pediatric patients. Invasive Pressure Monitoring: Indications The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient.

Source page: https://510kreport.com/device/K102972
Methodology: https://510kreport.com/methodology