Cleared Traditional

K864267 - SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)

K864267 is an FDA 510(k) clearance for SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY), manufactured by Millipore Corp.. The device is a Class 1 Chemistry device with product code DPM cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K864267 · Millipore Corp. · Chemistry device
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Jan 1987
Decision
72d
Days
Class 1
Risk

K864267 is an FDA 510(k) clearance for the SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY). Classified as Columns, Liquid Chromatography (product code DPM), Class I - General Controls.

Submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on January 9, 1987 after a review of 72 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 - K864267

510(k) Number K864267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1986
Decision Date January 09, 1987
Days to Decision 72 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
16d faster than avg
Panel avg: 88d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

DPM Device Classification - Class 1, General Controls

Product Code DPM Columns, 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 - DPM Columns, Liquid Chromatography

All 10
Devices cleared under the same product code (DPM) and FDA review panel - the closest regulatory comparables to K864267.
LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE
K884403 · Supelco, Inc. · Dec 1988
LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD
K881868 · Supelco, Inc. · Aug 1988
LIQUID CHROMATO. COLUMNS
K880724 · Supelco, Inc. · May 1988
LIQUID CHROMATOGRAPHY COLUMNS
K862541 · Supelco, Inc. · Jul 1986
LIQUID CHROMATOGRAPHY COLUMNS
K861633 · Supelco, Inc. · May 1986
LIQUID CHROMATOGRAPHY COLUMNS
K842909 · Supelco, Inc. · Oct 1984