Cleared Traditional

AVL MODEL 940 AUTOMATIC PH/BLOOD GAS (K792230) - FDA 510(k) Clearance

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

K792230 · Gauntlet Technology Corp. · Chemistry device
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Dec 1979
Decision
56d
Days
Class 2
Risk

K792230 is an FDA 510(k) clearance for the AVL MODEL 940 AUTOMATIC PH/BLOOD GAS. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Gauntlet Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1979 after a review of 56 days - a notably fast clearance 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: 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 Gauntlet Technology Corp. devices

Submission Details

510(k) Number K792230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1979
Decision Date December 31, 1979
Days to Decision 56 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 faster than avg
Panel avg: 88d · This submission: 56d
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 32
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K792230.
IL 1302 PH BLOOD GAS ANALYZER
K821483 · Instrumentation Laboratory CO · Jun 1982
IL MODEL 1301, PH BLOOD GAS SYSTEM
K820744 · Instrumentation Laboratory CO · Apr 1982
IL MODEL 1303 PH/BLOOD GAS ANALYZER
K800757 · Instrumentation Laboratory CO · Apr 1980
HEMOX-ANALYZER
K771253 · 3M Company · Aug 1977
PH/BLOOD GAS SYSTEM
K760969 · Instrumentation Laboratory CO · Jan 1977