Cleared Traditional

K895317 - AVL MODEL 995HB PH/BLOOD GAS ANALYZER

K895317 is the FDA 510(k) clearance for AVL MODEL 995HB PH/BLOOD GAS ANALYZER by Avl Scientific Corp.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K895317 · Avl Scientific Corp. · Chemistry device
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Feb 1990
Decision
156d
Days
Class 2
Risk

K895317 is an FDA 510(k) clearance for the AVL MODEL 995HB PH/BLOOD GAS ANALYZER. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on February 1, 1990 after a review of 156 days - an extended review 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: 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

Submission Details

510(k) Number K895317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1989
Decision Date February 01, 1990
Days to Decision 156 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
68d slower than avg
Panel avg: 88d · This submission: 156d
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 130
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K895317.
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K895181 · Radiometer America, Inc. · Oct 1989
IL1400, BGELECTROLYTE ANALYZER
K890827 · Instrumentation Laboratory CO · Jun 1989
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K891578 · Avl Scientific Corp. · May 1989