Cleared Traditional

K922631 - STATPAL II BLOOD GAS ANALYSIS SYSTEM

K922631 is the FDA 510(k) clearance for STATPAL II BLOOD GAS ANALYSIS SYSTEM by Ppg Industries, Inc.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K922631 · Ppg Industries, Inc. · Chemistry device
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Nov 1992
Decision
160d
Days
Class 2
Risk

K922631 is an FDA 510(k) clearance for the STATPAL II BLOOD GAS ANALYSIS SYSTEM. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (La Jolla, US). The FDA issued a Cleared decision on November 10, 1992 after a review of 160 days - an extended review cycle.

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 Ppg Industries, Inc. devices

Submission Details

510(k) Number K922631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1992
Decision Date November 10, 1992
Days to Decision 160 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 88d · This submission: 160d
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 84
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