Cleared Traditional

K922388 - WATERS(TM) LC MODULE I FOR CLINICAL USE

K922388 is an FDA 510(k) clearance for WATERS(TM) LC MODULE I FOR CLINICAL USE, manufactured by Millipore Corp.. The device is a Class 1 Toxicology device with product code LDM cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K922388 · Millipore Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K922388

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 87d · This submission: 114d
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 K922388.
CDM
K960392 · Bio-Rad · Jul 1996
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
K942451 · Bio-Rad · Nov 1994
WATERS 717 AUTOSAMPLER
K920136 · Millipore Corp. · Feb 1992
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE
K903647 · Millipore Corp. · Sep 1990
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
K884886 · The Perkin-Elmer Corp. · Feb 1989
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM
K872582 · Millipore Corp. · Jul 1987