# K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Physio-Control Corp.
- Decided: Feb 5, 2002 after 201 days
- Product code: LDD (Dc-Defibrillator, Low-Energy, (Including Paddles))
- Device class: 2
- Regulation: 21 CFR 870.5300
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921669 (1993). 17 ancestors in all.
21 later devices descend from it; 4 cite it directly.
4 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802288: Swan Ganz Catheter Placement Kit, Stanco Medical, Inc. (1980) Summary page 2.
- K973486: Life Pak 12, Physio-Control Corp. (1998) Summary page 2.
- K991910: Lifepak 12 Biphasic, Physio-Control Corp. (1999) Summary page 2.

## Most influential descendants
- K033275: Lifepak 12, 20, 500, CR Plus (2003), 20 descendants of its own
- K040775: Lifepak 12 (2004), 10 descendants of its own
- 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

## Recalls of this device
- May 27, 2010 · Not classified · Z-1722-2011: A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted.
- May 27, 2010 · Not classified · Z-1903-2010: A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power." A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power 
- Dec 30, 2008 · Not classified · Z-0185-2012: When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.
- Jun 18, 2008 · Not classified · Z-2388-2008: Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.
- Jan 8, 2008 · Not classified · Z-1050-2008: Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).
- Apr 27, 2007 · Not classified · Z-0925-2007: White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting i
- Mar 30, 2007 · Not classified · Z-0886-2007: Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.
- Aug 30, 2006 · Not classified · Z-1502-06: Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning.
- Mar 22, 2006 · Not classified · Z-0711-06: Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defib
- Mar 16, 2006 · Not classified · Z-0295-2007: LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.
- Sep 2, 2005 · Not classified · Z-0117-06: Potential for voltage pins in connector of therapy cable to break.
- Sep 2, 2005 · Not classified · Z-0116-06: Potential for voltage pins in connector of therapy cable to break.
- Jun 17, 2005 · Not classified · Z-0984-05: The defibrillator may not operate if the device is turned on during an AC Loss Alert.
- May 5, 2004 · Not classified · Z-0971-04: The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor.
- May 5, 2004 · Not classified · Z-1107-04: Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resis
- Apr 5, 2004 · Not classified · Z-0938-04: Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.
- Nov 12, 2003 · Not classified · Z-0294-04: Device unable to recognize the connection to the hard paddles accessory.

## Indications for use
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. The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients. The AED 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 20 defibrillator/monitor is not intended for use on pediatric patients less than eight years old. Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.

Source page: https://510kreport.com/device/K012274
Methodology: https://510kreport.com/methodology