Cleared Traditional

K895105 - HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE

K895105 is an FDA 510(k) clearance for HIGH PRESSURE INERT PLASTIC COLUMNS FOR..., manufactured by Waters Chemical Products. The device is a Class 1 Chemistry device with product code DPM cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K895105 · Waters Chemical Products · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
52d
Days
Class 1
Risk

K895105 is an FDA 510(k) clearance for the HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE. Classified as Columns, Liquid Chromatography (product code DPM), Class I - General Controls.

Submitted by Waters Chemical Products (Milford, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 52 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 Waters Chemical Products devices

FDA 510(k) Submission Details - K895105

510(k) Number K895105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1989
Decision Date October 06, 1989
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 88d · This submission: 52d
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 11
Devices cleared under the same product code (DPM) and FDA review panel - the closest regulatory comparables to K895105.
LIQUID CHROMATOGRAPHY COLUMNS
K894141 · Supelco, Inc. · Aug 1989
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
SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)
K864267 · Millipore Corp. · Jan 1987
LIQUID CHROMATOGRAPHY COLUMNS
K862541 · Supelco, Inc. · Jul 1986