Cleared Traditional

POTASSIUM ANALYZER-SODIUM/ELECTROLYTE (K830588) - FDA 510(k) Clearance

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

K830588 · Shaban Mfg. Co. · Chemistry device
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Apr 1983
Decision
63d
Days
Class 2
Risk

K830588 is an FDA 510(k) clearance for the POTASSIUM ANALYZER-SODIUM/ELECTROLYTE. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Shaban Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1983 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 Shaban Mfg. Co. devices

Submission Details

510(k) Number K830588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date April 27, 1983
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 43
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K830588.
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473 · Roche Diagnostic Systems, Inc. · Jul 1985
TECHNICON RA-1000 SYSTEM
K833992 · Technicon Instruments Corp. · Jan 1984
TECHNICON RA-1000 SYS-ISE MODULE &
K833072 · Technicon Instruments Corp. · Nov 1983
BECKMAN ASTRA
K822039 · Beckman Instruments, Inc. · Oct 1982
IL 501, NA/K ANALYZER
K812762 · Instrumentation Laboratory CO · Oct 1981
BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM
K801896 · Beckman Instruments, Inc. · Sep 1980