# P160026: Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak 15 Monitor/DE

- Pathway: PMA
- Applicant: Physio-Control, Inc.
- Decided: Jul 2, 2018 after 707 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 13, 2026 · Class II · Z-2065-2026: Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform 
- Jul 22, 2025 · Class II · Z-2497-2025: Due to required inspections not being performed on products/units that have gone through servicing.
- Jul 22, 2025 · Class II · Z-2498-2025: Due to required inspections not being performed on products/units that have gone through servicing.
- Feb 3, 2025 · Class II · Z-1232-2025: Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- Jan 21, 2025 · Class II · Z-1184-2025: Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
- Aug 30, 2024 · Class II · Z-0230-2025: Due to an out of tolerance tool being used on monitor/defibrillator systems.
- Nov 6, 2023 · Class II · Z-0567-2024: AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
- Sep 29, 2023 · Class II · Z-0296-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Sep 29, 2023 · Class II · Z-0297-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Sep 29, 2023 · Class II · Z-0300-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Sep 29, 2023 · Class II · Z-0301-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Sep 29, 2023 · Class II · Z-0299-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Sep 29, 2023 · Class II · Z-0303-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Sep 29, 2023 · Class II · Z-0304-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Sep 29, 2023 · Class II · Z-0298-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Sep 29, 2023 · Class II · Z-0302-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Sep 29, 2023 · Class II · Z-0305-2024: Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

Source page: https://510kreport.com/device/P160026
Methodology: https://510kreport.com/methodology