# K063119: Lifepak 20 Defibrillator/ Monitor

- Pathway: 510(k) (Special)
- Applicant: Medtronic Emergency Response Systems, Inc.
- Decided: Dec 22, 2006 after 71 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 5 (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). 22 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 25 devices in its family (counting itself) has 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 2.
- K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker, Medtronic Physio-Control Corp. (2002) Summary page 2.

## Most influential descendants
- K073089: Lifepak 20E (2008), 1 descendant of its own
- K130454: Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/Monitor (2013), 0 descendants of its own

## Recalls of this device
- May 13, 2008 · Not classified · Z-2010-2008: A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic externa
- May 13, 2008 · Not classified · Z-2009-2008: A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external def
- May 13, 2008 · Not classified · Z-2011-2008: A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic externa
- Apr 16, 2008 · Not classified · Z-1906-2008: The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is O
- Apr 16, 2008 · Not classified · Z-1905-2008: The LIFEPAK 20 defibrillator / monitors with software versions 048, 052 and 054 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in A

## Indications for use
Manual Defibrillation: Indications: Defibrillation is a recognized means of terminating certain 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. The biphasic defibrillation waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients. 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 patient's ECG rhythm. In AED mode, the LIFEPAK 20 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 Oximetry Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.

Source page: https://510kreport.com/device/K063119
Methodology: https://510kreport.com/methodology