# K011144: Lifepak 600 Automated External Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Physio-Control Corp.
- Decided: Dec 3, 2001 after 231 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- K040438: Powerheart Aed G3A (2004), 6 descendants of its own

## Recalls of this device
- Feb 8, 2013 · Class II · Z-1082-2013: LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
- Jul 31, 2009 · Not classified · Z-2030-2009: The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SA
- Aug 28, 2008 · Not classified · Z-2341-2008: This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergenc
- Jul 24, 2008 · Not classified · Z-0149-2009: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
- Jul 24, 2008 · Not classified · Z-0150-2009: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
- Mar 2, 2007 · Not classified · Z-0671-2007: LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate
- Oct 5, 2006 · Not classified · Z-0836-2007: Premature battery depletion due to electrical component failure
- Oct 5, 2006 · Not classified · Z-0837-2007: Premature battery depletion due to electrical component failure
- May 23, 2003 · Not classified · Z-0940-03: Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.

Source page: https://510kreport.com/device/K011144
Methodology: https://510kreport.com/methodology