# K971237: Alexander Manufacturing CO. Rechargeable Battery Part Number GL8108

- 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 K811238 (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)
- K811238: Model 560 Series Volumetric Infusion, Y (1981) Summary page 3.

## Indications for use
Replacement battery for IVAC Corp. 0810-0008 560/560 Plus/565/570 Models Variable Pressure Pump, 510(k) Number K811238. This battery is shnpped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician theretore knows the intended use is as a replacement battery.

Source page: https://510kreport.com/device/K971237
Methodology: https://510kreport.com/methodology