# K981294: Odyssey Instrumentation System

- Pathway: 510(k) (Traditional)
- Applicant: Automata Instrumentation, Inc.
- Decided: Jul 8, 1998 after 90 days
- Product code: FIZ (Meter, Conductivity, Non-Remote)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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
The ODYSSEY Instrumentation System is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the ODYSSEY Instrumentation System to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and adjusting to maintain safe and effective hemodialysis systems.

Source page: https://510kreport.com/device/K981294
Methodology: https://510kreport.com/methodology