Cleared Traditional

K831387 - HS-100 HEADSPACE SAMPLING ACCESSORY (FDA 510(k) Clearance)

Class I Toxicology device.

K831387 · The Perkin-Elmer Corp. · Toxicology device
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Aug 1983
Decision
118d
Days
Class 1
Risk

K831387 is an FDA 510(k) clearance for the HS-100 HEADSPACE SAMPLING ACCESSORY. Classified as Chromatography(gas), Clinical Use (product code KZQ), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1983 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Perkin-Elmer Corp. devices

Submission Details

510(k) Number K831387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1983
Decision Date August 24, 1983
Days to Decision 118 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 87d · This submission: 118d
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.