Cleared Traditional

WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM (K872792) - FDA 510(k) Clearance

K872792 · Millipore Corp. · Chemistry device
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Jul 1987
Decision
17d
Days
-
Risk

K872792 is an FDA 510(k) clearance for the WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM.

Submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on July 31, 1987 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel. 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 K872792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1987
Decision Date July 31, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -