Cleared Traditional

K920061 - HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920061 · Abbott Laboratories · Anesthesiology device
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Mar 1992
Decision
83d
Days
Class 2
Risk

K920061 is an FDA 510(k) clearance for the HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM. Classified as Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling (product code CBZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 30, 1992 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1170 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K920061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1992
Decision Date March 30, 1992
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 139d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBZ Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1170
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.