# K012428: Modification to: Lifepak 500 Automated External Defibrillator

- Pathway: 510(k) (Special)
- Applicant: Medtronic Physio-Control Corp.
- Decided: Sep 28, 2001 after 59 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943301 (1995). 7 ancestors in all.
21 later devices descend from it; 2 cite it directly.
4 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983393: Lifepak 500 Biphasic, Physio-Control Corp. (1999) Summary page 1.
- K955854: Lifepak 500, Physio-Control Corp. (1996) Summary page 1.

## 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
- 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
- Apr 2, 2004 · Not classified · Z-0886-04: Potential for batteries to malfunction due to battery cell rupture.

## 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, no coughing, no movement) before the device is used to analyze the patient’s ECG rhythm. This device is not intended for use on children less than eight years of age, per AHA/ILCOR Guidelines.

Source page: https://510kreport.com/device/K012428
Methodology: https://510kreport.com/methodology