Cleared Traditional

K895317 - AVL MODEL 995HB PH/BLOOD GAS ANALYZER

K895317 is an FDA 510(k) clearance for AVL MODEL 995HB PH/BLOOD GAS ANALYZER, 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 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

FDA 510(k) Submission Details - K895317

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.

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 K895317.
ABL510 BLOOD GAS SYSTEM
K904513 · Radiometer America, Inc. · Dec 1990
CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER
K904188 · Ciba Corning Diagnostics Corp. · Sep 1990
BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS
K902267 · Phoenix Diagnostics, Inc. · Jun 1990
ABL500 BLOOD GAS SYSTEM
K895181 · Radiometer America, Inc. · Oct 1989
IL1400, BGELECTROLYTE ANALYZER
K890827 · Instrumentation Laboratory CO · Jun 1989
AVL MODEL 987 ELECTROLYTE ANALYZER
K891578 · Avl Scientific Corp. · May 1989