# K030261: Battery, Rechargeable

- Pathway: 510(k) (Traditional)
- Applicant: Access Battery, Inc.
- Decided: Apr 24, 2003 after 90 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Rechargeable batteries are utilized in portable medical equipment as a primary d-c power source or as a stand-by or backup d-c power source for portable as well as stationary medical equipment with a-c providing the primary power. These devices are copies of Original Equipment Manufacturer (OEM) or After-Market battery packs currently on the market. A sample is generally submitted by Hospitals, Medical Centers, and Biomedical or Clinical Engineering Service Professionals for duplication. There is no direct contact with the OEM’s or access to their equipment for testing purposes. The end-user provides feedback and assists in qualifying the device as to its performance, form, fit or function although we incorporate all available resources to assist us in producing a device that meets or exceeds OEM specifications. It is this process that the majority of after-market manufacturers utilize in order to duplicate battery packs for sale as replacements for the original or predicate device. Battery packs are “device specific” and are designed to operate and fit into those OEM devices for which they were manufactured. Therefore, only qualified personnel should evaluate, test, or install these devices.

Source page: https://510kreport.com/device/K030261
Methodology: https://510kreport.com/methodology