# K062331: Highpak-12

- Pathway: 510(k) (Traditional)
- Applicant: Ad Elektronik GmbH
- Decided: Jul 10, 2007 after 334 days
- Product code: MPD (Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator)
- Device class: 2
- Regulation: 21 CFR 870.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921669 (1993). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041459: Lifepak 12 Defibrillator/Monitor, Medtronic Emergency Response Systems, Inc. (2004) Summary page 1.
- K040775: Lifepak 12, Medtronic Physio-Control Corp. (2004) Summary page 1.
- K010918: Lifepak 12 Defibrillator/Monitor System, Medtronic Physio-Control Corp. (2001) Summary page 1.
- K002445: Lifepak 12DEFIBERLLATOR/Monitor Series, Medtronic Physio-Control Corp. (2001) Summary page 1.
- K991910: Lifepak 12 Biphasic, Physio-Control Corp. (1999) Summary page 1.

## Indications for use
The HighPak® -12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.

Source page: https://510kreport.com/device/K062331
Methodology: https://510kreport.com/methodology