# K130454: Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control, Inc.
- Decided: Aug 21, 2013 after 180 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K921669 (1993). 34 ancestors in all.
No later device cites it as a predicate yet.
1 of 35 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker, Medtronic Physio-Control Corp. (2002)
- K033275: Lifepak 12, 20, 500, CR Plus, Medtronic Physio-Control Corp. (2003) Summary page 2.
- K063119: Lifepak 20 Defibrillator/ Monitor, Medtronic Emergency Response Systems, Inc. (2006) Summary page 2.
- K073089: Lifepak 20E, Physio-Control, Inc. (2008) Summary page 2.
- K082937: Lifepak 15 Monitor/Defibrillator, Physio-Control, Inc. (2009) Summary page 2.
- K103567: Lifepak 15 Monitor/Defibrillator, Physio-Control, Inc. (2011) Summary page 2.

## Recalls of this device
- Dec 4, 2017 · Class I · Z-0294-2018: Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of

## Indications for use
Manual Defibrillation Indications: Defibrillation is a recognized means of terminating 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, atria] 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 idioventricular escape rhythms, and in the treatment of asystole. Automated External Defibrillation: Indications: The 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 patients ECG rhythm. In AED mode, the LIFEPAK 20 (and LIFEPAK 20e) 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. Pulse Oximotry Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia. End-Tidal CO2 monitoring: Indications: EtCO 2 monitoring is used to detect 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.

Source page: https://510kreport.com/device/K130454
Methodology: https://510kreport.com/methodology