Cleared Traditional

K831379 - MODEL 947 VIDEO BLOOD GAS SYS

K831379 is an FDA 510(k) clearance for MODEL 947 VIDEO BLOOD GAS SYS, manufactured by Avl Scientific Corp.. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K831379 · Avl Scientific Corp. · Chemistry device
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Jul 1983
Decision
91d
Days
Class 2
Risk

K831379 is an FDA 510(k) clearance for the MODEL 947 VIDEO BLOOD GAS SYS. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Avl Scientific Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983 after a review of 91 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 Avl Scientific Corp. devices

FDA 510(k) Submission Details - K831379

510(k) Number K831379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1983
Decision Date July 28, 1983
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHL Device Classification - Class 2, Special Controls

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 160
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K831379.
PARTIAL PRESSURE ELECTRODE MEASUREMENT
K833536 · Shaban Mfg. Co. · Dec 1983
ELECTRODES FOR BLOOD GAS ANALYZERS
K832981 · Analytical Products, Inc. · Oct 1983
REFEREE BLOOD GAS ANALYZER-ELECTRODES
K832779 · Analytical Products, Inc. · Oct 1983
CALIBRATING SOLUTION FOR ABL-1 & 2
K831018 · Fisher Scientific Co., LLC · Jun 1983
PH 6.838 REF. BUFFER
K831019 · Fisher Scientific Co., LLC · Jun 1983
CALIBRATING SOLUTION FOR ABL-1 & 2
K831021 · Fisher Scientific Co., LLC · Jun 1983