Cleared Traditional

K850272 - WATERS 740 DATA MODULE-PLOTTER INTEGRATOR (FDA 510(k) Clearance)

Class I Toxicology device.

K850272 · Millipore Corp. · Toxicology device
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Mar 1985
Decision
42d
Days
Class 1
Risk

K850272 is an FDA 510(k) clearance for the WATERS 740 DATA MODULE-PLOTTER INTEGRATOR. 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 March 6, 1985 after a review of 42 days - a notably fast clearance cycle.

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: 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 Millipore Corp. devices

Submission Details

510(k) Number K850272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1985
Decision Date March 06, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 87d · This submission: 42d
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.