Cleared Traditional

K833159 - POTASSIUM ELECTRODE TIP ASSAMBLY-K-

K833159 is the FDA 510(k) clearance for POTASSIUM ELECTRODE TIP ASSAMBLY-K- by Hi Chem, Inc.. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K833159 · Hi Chem, Inc. · Chemistry device
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Nov 1983
Decision
70d
Days
Class 2
Risk

K833159 is an FDA 510(k) clearance for the POTASSIUM ELECTRODE TIP ASSAMBLY-K-. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Hi Chem, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 25, 1983 after a review of 70 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 Hi Chem, Inc. devices

Submission Details

510(k) Number K833159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1983
Decision Date November 25, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
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 52
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K833159.
AMRESCO E2A REAGENT SET 0562 & 0626
K840887 · American Research Products Co. · Apr 1984
ACID BASE LABORATORY ABL4
K833696 · Radiometer America, Inc. · Jan 1984
QEA SODIUM/POTASSIUM ANALYZER
K833776 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1983
QEA SODIUM/POTASSIUM ANALYZER
K832036 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1983
SERUM IRON DIAGNOSTIC TEST KITS
K830104 · Sclavo, Inc. · Jan 1983
UNIMETER 330K
K822441 · Boehringer Mannheim Corp. · Oct 1982