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Odyssey Instrumentation System

by Automata Instrumentation, Inc.

510(k) K981294

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981294 Date8 Jul 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FIZ
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Odyssey Instrumentation System is a non-remote conductivity meter (Product Code: FIZ) designed for monitoring hemodialysis and water purification systems. It measures key parameters—conductivity, temperature, pH, and pressure—to assess dialysate solution and water quality, ensuring system performance integrity in clinical and laboratory settings.

This device is intended for single-use or reusable applications in hemodialysis and urology environments, adhering to FDA 510(k) clearance (K981294) under regulatory classification 2. Supplied as a standalone instrumentation tool, it requires proper calibration and maintenance per manufacturer guidelines. No specific sterility or MRI safety data is provided in the regulatory submission.

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