Cleared Traditional

K850359 - WATERS 460 LIQUID CHROMATOGRAPHY ELECTR...

K850359 is an FDA 510(k) clearance for WATERS 460 LIQUID CHROMATOGRAPHY ELECTR..., manufactured by Millipore Corp.. The device is a Class 1 Chemistry device with product code LDM cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K850359 · Millipore Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
34d
Days
Class 1
Risk

K850359 is an FDA 510(k) clearance for the WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D. 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 5, 1985 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2260 - the FDA in vitro diagnostics and chemistry 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

FDA 510(k) Submission Details - K850359

510(k) Number K850359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1985
Decision Date March 05, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

LDM Device Classification - Class 1, General Controls

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 17
Devices cleared under the same product code (LDM) and FDA review panel - the closest regulatory comparables to K850359.
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM
K870949 · Millipore Corp. · Apr 1987
ISOPURE LC SYSTEM
K862178 · The Perkin-Elmer Corp. · Jul 1986
WATERS 740 DATA MODULE-PLOTTER INTEGRATOR
K850272 · Millipore Corp. · Mar 1985
REPORTING INTEGRATOR 3392A
K833113 · Hewlett-Packard Co. · Nov 1983
LIQUID CHROMATOGRAPH 1090 SERIES
K832375 · Hewlett-Packard Co. · Oct 1983
SERIES 10 LIQUID CHROMOTOGRAPH
K821727 · The Perkin-Elmer Corp. · Jun 1982