# K971213: Alexander Manufacturing CO. Rechargeable Battery # GL825-P

- Pathway: 510(k) (Traditional)
- Applicant: Alexander Mfg. Co.
- Decided: May 27, 1997 after 55 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K813403 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813403: Flo-Gard 8000 Infusion Pump System, Travenol Laboratories, S.A. (1981) Summary page 3.

## Indications for use
Replacement battery for Baxter 64276002002 Flo-Guard 8000, 8100, 8200 Infusion Pumps (controller), 510(k) Number K813403. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Source page: https://510kreport.com/device/K971213
Methodology: https://510kreport.com/methodology