Cleared Traditional

K833534 - PARTIAL PRESSURE ELECTRODE MEASUREMENT

K833534 is the FDA 510(k) clearance for PARTIAL PRESSURE ELECTRODE MEASUREMENT by Shaban Mfg. Co.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K833534 · Shaban Mfg. Co. · Chemistry device
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Dec 1983
Decision
93d
Days
Class 2
Risk

K833534 is an FDA 510(k) clearance for the PARTIAL PRESSURE ELECTRODE MEASUREMENT. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Shaban Mfg. Co. (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Shaban Mfg. Co. devices

Submission Details

510(k) Number K833534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1983
Decision Date December 29, 1983
Days to Decision 93 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
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 126
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K833534.
POTASSIUM CHLORIDE TABLETS
K840843 · Bionostics, Inc. · Apr 1984
PARTIAL PRESS. ELECTRODE MEASUREMENT
K840468 · Shaban Mfg. Co. · Mar 1984
FLUSH SOLUTION CONCENTRATE-BLOOD GAS
K840300 · Bionostics, Inc. · Mar 1984
PARTIAL PRESSURE ELECTRODE MEASUREMENT
K833536 · Shaban Mfg. Co. · Dec 1983
ELECTRODES FOR BLOOD GAS ANALYZERS
K832981 · Analytical Products, Inc. · Oct 1983
REFEREE BLOOD GAS ANALYZER-ELECTRODES
K832779 · Analytical Products, Inc. · Oct 1983