Cleared Traditional

K922388 - WATERS(TM) LC MODULE I FOR CLINICAL USE (FDA 510(k) Clearance)

Class I Toxicology device.

K922388 · Millipore Corp. · Toxicology device
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Sep 1992
Decision
114d
Days
Class 1
Risk

K922388 is an FDA 510(k) clearance for the WATERS(TM) LC MODULE I FOR CLINICAL USE. Classified as Instrumentation, High Pressure Liquid Chromatography (product code LDM), Class I - General Controls.

Submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2260 - 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 Millipore Corp. devices

Submission Details

510(k) Number K922388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date September 11, 1992
Days to Decision 114 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 87d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDM Instrumentation, High Pressure Liquid Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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.