Cleared Traditional

K896311 - OPTEX BLOOD GAS MONITORING SYSTEM

K896311 is the FDA 510(k) clearance for OPTEX BLOOD GAS MONITORING SYSTEM by Optex Biomedical. It is a Class 2 Anesthesiology device (product code CCE) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K896311 · Optex Biomedical · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jan 1990
Decision
63d
Days
Class 2
Risk

K896311 is an FDA 510(k) clearance for the OPTEX BLOOD GAS MONITORING SYSTEM. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Optex Biomedical (The Woodlands, US). The FDA issued a Cleared decision on January 3, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1200 - the FDA anesthesiology and respiratory device 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 Optex Biomedical devices

Submission Details

510(k) Number K896311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1989
Decision Date January 03, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 140d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1200
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

All 8
Devices cleared under the same product code (CCE) and FDA review panel - the closest regulatory comparables to K896311.
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