Cleared Traditional

K914841 - CHROMATOGRAPHY CLINICAL USE 75JQR

K914841 is an FDA 510(k) clearance for CHROMATOGRAPHY CLINICAL USE 75JQR, 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 46-day FDA review.

K914841 · Millipore Corp. · Toxicology device
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Dec 1991
Decision
46d
Days
Class 1
Risk

K914841 is an FDA 510(k) clearance for the CHROMATOGRAPHY CLINICAL USE 75JQR. 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 10, 1991 after a review of 46 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 Millipore Corp. devices

FDA 510(k) Submission Details - K914841

510(k) Number K914841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1991
Decision Date December 10, 1991
Days to Decision 46 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
41d faster than avg
Panel avg: 87d · This submission: 46d
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 K914841.
PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
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THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
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EMIT ANCILLARY REAGENTS
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SYVA SAMPLE SEAL
K844949 · Syva Co. · Feb 1985
DIFFERENTIAL REFRACTIVE INDEX DETECTOR
K800556 · Hewlett-Packard Co. · Mar 1980