Cleared Traditional

CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (K874824) - FDA 510(k) Clearance

Class I Toxicology device.

K874824 · Supelco, Inc. · Toxicology device
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Jan 1988
Decision
58d
Days
Class 1
Risk

K874824 is an FDA 510(k) clearance for the CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY. Classified as Columns, Glc (product code DII), Class I - General Controls.

Submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on January 21, 1988 after a review of 58 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 Supelco, Inc. devices

Submission Details

510(k) Number K874824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1987
Decision Date January 21, 1988
Days to Decision 58 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 87d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DII Columns, Glc
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.