# K122600: Lifepak 1000 Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control, Inc.
- Decided: Oct 11, 2012 after 45 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921669 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042404: Lifepak, Model 1000, Medtronic Emergency Response Systems, Inc. (2005) Summary page 2.

## Recalls of this device
- Jan 13, 2017 · Class I · Z-1257-2017: The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.

## 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 (55 lbs). 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/K122600
Methodology: https://510kreport.com/methodology