# K042404: Lifepak, Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Emergency Response Systems, Inc.
- Decided: Dec 22, 2005 after 475 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: 6 generations back to K921669 (1993). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983393: Lifepak 500 Biphasic, Physio-Control Corp. (1999) 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.
- K014157: HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A, Philips Medical Systems (2002) Summary page 1.

## Most influential descendants
- K122600: Lifepak 1000 Defibrillator (2012), 0 descendants of its own

## Recalls of this device
- May 9, 2014 · Class II · Z-1660-2014: Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator
- Feb 27, 2008 · Not classified · Z-1656-2008: Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or perman

## Indications for use
Defibrillation: Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (551bs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes. ECG Monitoring: ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

Source page: https://510kreport.com/device/K042404
Methodology: https://510kreport.com/methodology