# K072596: Life+Cel or Lifecel Battery Pack, Model 5L500

- Pathway: 510(k) (Traditional)
- Applicant: Amco International Manufacturing & Design, Inc.
- Decided: Jan 24, 2008 after 132 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921669 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052057: Lifepak 500 Automated External Defibrillator, Medtronic Emergency Response Systems, Inc. (2006) Summary page 6.

## Indications for use
The 5L500 Lithium life+cel or lifecel is a replacement battery pack for the Medtronic LifePak 500 AED. Since non-rechargeable batteries and battery packs are "device specific", and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals, EMT's, etc. therefore know that the intended use is as a replacement battery. The replacement battery pack in this submission, Amco Part Number 5L500, is to be provided by prescription only.

Source page: https://510kreport.com/device/K072596
Methodology: https://510kreport.com/methodology