# K981776: Alexander Manufacturing CO. Battery Part Number MC146X

- Pathway: 510(k) (Traditional)
- Applicant: Alexander Mfg. Co.
- Decided: Aug 3, 1998 after 75 days
- Product code: FRN (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 K941984 (1994). 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)
- K941984: Sabratek 6060 Homerun Volumetric Infusion Pump, Sabratek Corp. (1994) Summary page 1.
- (no number) Other non-rechargeable 8.4 volt (9-volt) applications battery: named in the summary without a submission number

## Indications for use
Replacement battery for Sabretek 6060 Homerun Volumetric Infusion Pump (K941984) (and other non-rechargeable 8.4 volt (9-volt) applications). 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/K981776
Methodology: https://510kreport.com/methodology