Cleared Traditional

K924347 - WATERS(TM) 996 PDA

K924347 is an FDA 510(k) clearance for WATERS(TM) 996 PDA, manufactured by Millipore Corp.. The device is a Class 1 Toxicology device with product code KIE cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K924347 · Millipore Corp. · Toxicology device
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Dec 1992
Decision
106d
Days
Class 1
Risk

K924347 is an FDA 510(k) clearance for the WATERS(TM) 996 PDA. Classified as Apparatus, High Pressure Liquid Chromatography (product code KIE), Class I - General Controls.

Submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on December 11, 1992 after a review of 106 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 - K924347

510(k) Number K924347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1992
Decision Date December 11, 1992
Days to Decision 106 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
19d slower than avg
Panel avg: 87d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

KIE Device Classification - Class 1, General Controls

Product Code KIE Apparatus, 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 - KIE Apparatus, High Pressure Liquid Chromatography

All 13
Devices cleared under the same product code (KIE) and FDA review panel - the closest regulatory comparables to K924347.
PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
K935666 · The Perkin-Elmer Corp. · Apr 1994
CHROMATOGRAPHY CLINICAL USE 75JQR
K914841 · Millipore Corp. · Dec 1991
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
K862506 · Millipore Corp. · Jul 1986
EMIT ANCILLARY REAGENTS
K844947 · Syva Co. · Jun 1985
SYVA SAMPLE SEAL
K844949 · Syva Co. · Feb 1985
DIFFERENTIAL REFRACTIVE INDEX DETECTOR
K800556 · Hewlett-Packard Co. · Mar 1980