# K973025: Fluid Centurion (4-100-00)

- Pathway: 510(k) (Traditional)
- Applicant: Northgate Technologies, Inc.
- Decided: Nov 20, 1997 after 98 days
- Product code: FLN (Monitor, Electric For Gravity Flow Infusion Systems)
- Device class: 2
- Regulation: 21 CFR 880.2420
- 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. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew Dyonics Levelert™ Fluid Level Sensor: named in the summary without a submission number

## Indications for use
THE NORTECH FLUID CENTURION UNIT IS INDICATED FOR USE WHERE POST-OPERATIVE iRRIGATOIN IS INDICATED.

Source page: https://510kreport.com/device/K973025
Methodology: https://510kreport.com/methodology