# K955854: Lifepak 500

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control Corp.
- Decided: Nov 4, 1996 after 312 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: 1 generation back to K943301 (1995). 2 ancestors in all.
27 later devices descend from it; 4 cite it directly.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943301: Quik Combo, Physio-Control Corp. (1995) Summary page 1.
- K940445: Vivalink Aed Defibrillator, Survivalink Corp. (1995) Summary page 1.

## Most influential descendants
- K983393: Lifepak 500 Biphasic (1999), 25 descendants of its own
- K991910: Lifepak 12 Biphasic (1999), 22 descendants of its own
- K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker (2002), 21 descendants of its own
- K012428: Modification to: Lifepak 500 Automated External Defibrillator (2001), 21 descendants of its own
- K033275: Lifepak 12, 20, 500, CR Plus (2003), 20 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 13, 2007 · Not classified · Z-1148-2007: Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.

## Indications for use
The LIFEPAK 500 Automated External Defibrillator may be used in the hospital or pre-hospital setting by authorized personnel to terminate certain potentially fatal cardiac arrhythmias.

Source page: https://510kreport.com/device/K955854
Methodology: https://510kreport.com/methodology