# K983393: Lifepak 500 Biphasic

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control Corp.
- Decided: May 5, 1999 after 222 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: 2 generations back to K943301 (1995). 6 ancestors in all.
25 later devices descend from it; 6 cite it directly.
4 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955854: Lifepak 500, Physio-Control Corp. (1996) Summary page 1.
- K832833: Personal Defibrillator, Physio-Control, Inc. (1984) Summary page 1.
- K955628: Fore Runner External Defibrillator/Defibrillator Pads, Heartstream, Inc. (1996) Summary page 1.
- K896919: Heartstart 3000, Laerdal Medical Corp. (1990) Summary page 1.
- (no number) Mine Safety Heart Aid defibrillator: named in the summary without a submission number
- (no number) CRC Heart Aid defibrillator: named in the summary without a submission number

## Most influential descendants
- 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
- K040775: Lifepak 12 (2004), 10 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

## Indications for use
The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patnent must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. [t is not intended for use on children less than eight years of age, per AttA @W . The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and have, at a minimum, the following skills and training: CPR training AED training equivalent to that recommended by the American heart Association Training in the use of the LIFEPAK 500 AED Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K983393
Methodology: https://510kreport.com/methodology