# K013133: Nordix Inc Rechargeable Battery Part Number 2116

- Pathway: 510(k) (Traditional)
- Applicant: Nordix, Inc.
- Decided: Nov 13, 2001 after 55 days
- Product code: MOQ (Battery, Replacement, Rechargeable)
- Device class: 1
- Regulation: 21 CFR 878.4820
- 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.

## Indications for use
Replacement Battery for Baxter Flo-Gard Pump 8000, 8100, 8200 Infusion Pumps This battery is sold only to customers who request a replacement battery for a particular device or to replace a competitor’s replacement battery. The biomedical equipment technician knows the intended use is as a replacement battery.

Source page: https://510kreport.com/device/K013133
Methodology: https://510kreport.com/methodology