# K971826: Alexander Manufacturing CO. Rechargeable Battery Part Number M12/500

- Pathway: 510(k) (Traditional)
- Applicant: Alexander Mfg. Co.
- Decided: Jul 3, 1997 after 48 days
- Product code: LDR (Controller, Infusion, Intravascular, Electronic)
- 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 K884307 (1988). 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)
- K884307: Ivac (R) Volumetric Controller - Model 262, Y (1988) Summary page 3.

## Indications for use
Replacement battery for IVAC Corp. 123233 230, 530, 600 Infusion Controller, 510(k) Number K884307. 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/K971826
Methodology: https://510kreport.com/methodology