Cleared Traditional

K834601 - AVL MODEL 945 BLOOD GAS SYSTEM

K834601 is the FDA 510(k) clearance for AVL MODEL 945 BLOOD GAS SYSTEM by Avl Scientific Corp.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K834601 · Avl Scientific Corp. · Chemistry device

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Mar 1984

Decision

70d

Days

Class 2

Risk

K834601 is an FDA 510(k) clearance for the AVL MODEL 945 BLOOD GAS SYSTEM. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Avl Scientific Corp. (Walker, US). The FDA issued a Cleared decision on March 9, 1984 after a review of 70 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 Avl Scientific Corp. devices

Submission Details

510(k) Number	K834601 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 30, 1983
Decision Date	March 09, 1984
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

18d faster than avg

Panel avg: 88d · This submission: 70d

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 127

Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K834601.

POTASSIUM CHLORIDE TABLETS

K840843 · Bionostics, Inc. · Apr 1984

PARTIAL PRESS. ELECTRODE MEASUREMENT

K840468 · Shaban Mfg. Co. · Mar 1984

FLUSH SOLUTION CONCENTRATE-BLOOD GAS

K840300 · Bionostics, Inc. · Mar 1984

PARTIAL PRESSURE ELECTRODE MEASUREMENT

K833534 · Shaban Mfg. Co. · Dec 1983

PARTIAL PRESSURE ELECTRODE MEASUREMENT

K833536 · Shaban Mfg. Co. · Dec 1983

ELECTRODES FOR BLOOD GAS ANALYZERS

K832981 · Analytical Products, Inc. · Oct 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K834601

Avl Scientific Corp.

Walker, MI · US

Regulatory profile

33 submissions 33 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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