Cleared Traditional

K820025 - TRACE ANALYTICAL REDUCTION GAS ANALYZ

K820025 is the FDA 510(k) clearance for TRACE ANALYTICAL REDUCTION GAS ANALYZ by Trace Analytical. It is a Class 1 Toxicology device (product code KZQ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K820025 · Trace Analytical · Toxicology device
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Feb 1982
Decision
41d
Days
Class 1
Risk

K820025 is an FDA 510(k) clearance for the TRACE ANALYTICAL REDUCTION GAS ANALYZ. Classified as Chromatography(gas), Clinical Use (product code KZQ), Class I - General Controls.

Submitted by Trace Analytical (Mchenry, US). The FDA issued a Cleared decision on February 15, 1982 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2250 - the FDA toxicology device 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 Trace Analytical devices

Submission Details

510(k) Number K820025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1982
Decision Date February 15, 1982
Days to Decision 41 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 87d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZQ Chromatography(gas), Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KZQ Chromatography(gas), Clinical Use

All 10
Devices cleared under the same product code (KZQ) and FDA review panel - the closest regulatory comparables to K820025.
HS-100 HEADSPACE SAMPLING ACCESSORY
K831387 · The Perkin-Elmer Corp. · Aug 1983
SIGMA 300 GAS CHROMATROGRAPH
K830147 · The Perkin-Elmer Corp. · Feb 1983
SIGMA 2000 GAS CHROMATOGRAPH
K820283 · The Perkin-Elmer Corp. · Feb 1982
MODEL 5790 GAS CHROMATOGRAPH
K820071 · Hewlett-Packard Co. · Jan 1982
VISTA 44 GAS CHROMATOGRAPHY ANALYSIS
K801745 · Varian Assoc., Inc. · Aug 1980
5880 SERIES OF GAS CHROMATOGRAPHS
K791138 · Hewlett-Packard Co. · Jul 1979