# K002445: Lifepak 12DEFIBERLLATOR/Monitor Series

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Physio-Control Corp.
- Decided: Jan 31, 2001 after 175 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
No predicates in its family tree.
11 later devices descend from it; 6 cite it directly.
2 of 12 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
- 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
- K082937: Lifepak 15 Monitor/Defibrillator (2009), 5 descendants of its own
- K103567: Lifepak 15 Monitor/Defibrillator (2011), 4 descendants of its own

## Recalls of this device
- Jan 27, 2003 · Not classified · Z-0542-03: Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.

Source page: https://510kreport.com/device/K002445
Methodology: https://510kreport.com/methodology