Cleared Traditional

ALLIANCE 2690 SEPARATIONS MODULE (K961557) - FDA 510(k) Clearance

Class I Toxicology device.

K961557 · Waters Corporation · Toxicology device
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Jul 1996
Decision
74d
Days
Class 1
Risk

K961557 is an FDA 510(k) clearance for the ALLIANCE 2690 SEPARATIONS MODULE. Classified as Instrumentation, High Pressure Liquid Chromatography (product code LDM), Class I - General Controls.

Submitted by Waters Corporation (Milford, US). The FDA issued a Cleared decision on July 5, 1996 after a review of 74 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 Waters Corporation devices

Submission Details

510(k) Number K961557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date July 05, 1996
Days to Decision 74 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
13d faster than avg
Panel avg: 87d · This submission: 74d
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.

Regulatory Peers - LDM Instrumentation, High Pressure Liquid Chromatography

All 18
Devices cleared under the same product code (LDM) and FDA review panel - the closest regulatory comparables to K961557.
CDM
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K802031 · Hewlett-Packard Co. · Sep 1980
PREP I AUTOMATED SAMPLE PROCESSOR
K780933 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1978