# K963305: Alexander Box, Battery, Rechargeable

- Pathway: 510(k) (Traditional)
- Applicant: Alexander Mfg. Co.
- Decided: Apr 17, 1997 after 238 days
- Product code: BWA (Unit, Electrosurgical And Coagulation, With Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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.
- (no number) ANTEK Medical Telemetry: named in the summary without a submission number
- (no number) BIO-TEK Safety Analyzer Model 501: named in the summary without a submission number
- (no number) Corometrics Medical PH Meter: named in the summary without a submission number
- (no number) International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer: named in the summary without a submission number
- (no number) Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator: named in the summary without a submission number

## Indications for use
Power the ANTEK Medical Telemetry. Power the BIO-TEK Safety Analyzer Model 501. Power the Corometrics Medical PH Meter. Power the International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer. Power the Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator.

Source page: https://510kreport.com/device/K963305
Methodology: https://510kreport.com/methodology