Cleared Traditional

K903965 - STATPAL BLOOD GAS MONITORING SYSTEM

K903965 is the FDA 510(k) clearance for STATPAL BLOOD GAS MONITORING SYSTEM by Ppg Industries, Inc.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K903965 · Ppg Industries, Inc. · Chemistry device
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Dec 1990
Decision
120d
Days
Class 2
Risk

K903965 is an FDA 510(k) clearance for the STATPAL BLOOD GAS MONITORING 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 December 26, 1990 after a review of 120 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 Ppg Industries, Inc. devices

Submission Details

510(k) Number K903965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1990
Decision Date December 26, 1990
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 88d · This submission: 120d
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

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