# K033275: Lifepak 12, 20, 500, CR Plus

- Pathway: 510(k) (Special)
- Applicant: Medtronic Physio-Control Corp.
- Decided: Nov 6, 2003 after 27 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: 5 generations back to K921669 (1993). 21 ancestors in all.
20 later devices descend from it; 10 cite it directly.
4 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991910: Lifepak 12 Biphasic, Physio-Control Corp. (1999) Summary page 1.
- K010918: Lifepak 12 Defibrillator/Monitor System, Medtronic Physio-Control Corp. (2001)
- K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker, Medtronic Physio-Control Corp. (2002)
- K983393: Lifepak 500 Biphasic, Physio-Control Corp. (1999) Summary page 1.
- K012428: Modification to: Lifepak 500 Automated External Defibrillator, Medtronic Physio-Control Corp. (2001)
- K011144: Lifepak 600 Automated External Defibrillator, Medtronic Physio-Control Corp. (2001)

## Most influential descendants
- 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
- K103567: Lifepak 15 Monitor/Defibrillator (2011), 4 descendants of its own

## Recalls of this device
- May 25, 2016 · Class II · Z-2100-2016: LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (

## Indications for use
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 12 and LIFEPAK 20 defibrillatodmonitors are not intended for use on pediatric patients less than 8 years old. The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm. With Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb). The LIFEPAK CR Plus defibrillator is indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus defibrillator may be used on children up to 8 years old of 25kg (55 Ib).

Source page: https://510kreport.com/device/K033275
Methodology: https://510kreport.com/methodology