Cleared Traditional

POTASSIUM AND SODIUM ELECTROLYTE ANALYZER (K890792) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K890792 · Ionetics, Inc. · Chemistry device
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May 1989
Decision
75d
Days
Class 2
Risk

K890792 is an FDA 510(k) clearance for the POTASSIUM AND SODIUM ELECTROLYTE ANALYZER. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Ionetics, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on May 3, 1989 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ionetics, Inc. devices

Submission Details

510(k) Number K890792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1989
Decision Date May 03, 1989
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEM Electrode, Ion Specific, Potassium

All 25
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K890792.
ISE/K+
K912649 · Boehringer Mannheim Corp. · Jul 1991
LYTENING 2Z LYTENING SYSTEM 31
K900300 · Baxter Healthcare Corp · Mar 1990
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
K896692 · Baxter Healthcare Corp · Jan 1990
VISION LYTE (TM) POTASSIUM
K884566 · Abbott Laboratories · Dec 1988
IRON
K854298 · Boehringer Mannheim Corp. · Nov 1985
VISION POTASSIUM
K850950 · Abbott Laboratories · Aug 1985