Cleared Traditional

K861633 - LIQUID CHROMATOGRAPHY COLUMNS

K861633 is an FDA 510(k) clearance for LIQUID CHROMATOGRAPHY COLUMNS, manufactured by Supelco, Inc.. The device is a Class 1 Toxicology device with product code DPM cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K861633 · Supelco, Inc. · Toxicology device
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May 1986
Decision
24d
Days
Class 1
Risk

K861633 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPHY COLUMNS. Classified as Columns, Liquid Chromatography (product code DPM), Class I - General Controls.

Submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on May 23, 1986 after a review of 24 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 Supelco, Inc. devices

FDA 510(k) Submission Details - K861633

510(k) Number K861633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date May 23, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
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 K861633.
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
LIQUID CHROMATOGRAPHY COLUMNS
K842909 · Supelco, Inc. · Oct 1984
LIQUID CHROMATOGRAPHY (HPLC) COLUMNS
K813575 · Supelco, Inc. · Jan 1982
LIQUID CHROMATOGRAPHY COLUMNS
K811304 · Supelco, Inc. · May 1981