Cleared Traditional

K933370 - STOOL TRANSPORT/PROCESSOR (FDA 510(k) Clearance)

Class I Microbiology device.

K933370 · Sage Products, Inc. · Microbiology device
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Feb 1994
Decision
223d
Days
Class 1
Risk

K933370 is an FDA 510(k) clearance for the STOOL TRANSPORT/PROCESSOR. Classified as Device, Parasite Concentration (product code LKS), Class I - General Controls.

Submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 223 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K933370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1993
Decision Date February 17, 1994
Days to Decision 223 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 102d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKS Device, Parasite Concentration
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.