# K141795: Batter Pack, Replacement for Physio Control Lifepak 500

- Pathway: 510(k) (Traditional)
- Applicant: R & D Batteries, Inc.
- Decided: Dec 8, 2014 after 158 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
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. The FDA summary names its predicate without a number.
- (no number) AMCO Battery Pack P/N 5L500: named in the summary without a submission number

## Indications for use
To power the functions of various devices for which batteries or battery packs are configured. 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, or install these devices. This battery is shipped only to customers who request a replacement battery for a PhysioControl LP500 AED (OEM P/N: 3005380-026, 11141-00013) or to replace a competitor’s replacement battery for the same AED. Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.

Source page: https://510kreport.com/device/K141795
Methodology: https://510kreport.com/methodology
