# K052057: Lifepak 500 Automated External Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Emergency Response Systems, Inc.
- Decided: Feb 17, 2006 after 203 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 3 (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). 23 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955854: Lifepak 500, Physio-Control Corp. (1996) Summary page 1.
- K983393: Lifepak 500 Biphasic, Physio-Control Corp. (1999) Summary page 1.
- K012428: Modification to: Lifepak 500 Automated External Defibrillator, Medtronic Physio-Control Corp. (2001) Summary page 1.
- K033275: Lifepak 12, 20, 500, CR Plus, Medtronic Physio-Control Corp. (2003) Summary page 1.
- K013425: Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A, Philips Medical Systems (2002) Summary page 1.

## Most influential descendants
- K052465: Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351 (2006), 2 descendants of its own
- K123881: Heartsine Samaritan Pad 350P (2013), 1 descendant of its own
- K142709: samaritan PAD 450P (2015), 0 descendants of its own
- K072596: Life+Cel or Lifecel Battery Pack, Model 5L500 (2008), 0 descendants of its own

## Recalls of this device
- Mar 20, 2020 · Class II · Z-1633-2020: Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not re
- Jun 12, 2013 · Class II · Z-1773-2013: The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed 
- Jun 6, 2011 · Not classified · Z-2885-2011: The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly.

## Indications for use
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).

Source page: https://510kreport.com/device/K052057
Methodology: https://510kreport.com/methodology