Cleared Traditional

K833534 - PARTIAL PRESSURE ELECTRODE MEASUREMENT

K833534 is an FDA 510(k) clearance for PARTIAL PRESSURE ELECTRODE MEASUREMENT, manufactured by Shaban Mfg. Co.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K833534

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.

CHL Device Classification - Class 2, Special Controls

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 160
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K833534.
PARTIAL PRESS. ELECTRODE MEASUREMENT
K840468 · Shaban Mfg. Co. · Mar 1984
FLUSH SOLUTION CONCENTRATE-BLOOD GAS
K840300 · Bionostics, Inc. · Mar 1984
AVL MODEL 945 BLOOD GAS SYSTEM
K834601 · Avl Scientific Corp. · 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