Cleared Traditional

K881868 - LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD

K881868 is an FDA 510(k) clearance for LIQUID CHROMATOGRAPHY COLUMNS HISEP COL..., 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 118-day FDA review.

K881868 · Supelco, Inc. · Toxicology device
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Aug 1988
Decision
118d
Days
Class 1
Risk

K881868 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD. 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 August 29, 1988 after a review of 118 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 Supelco, Inc. devices

FDA 510(k) Submission Details - K881868

510(k) Number K881868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1988
Decision Date August 29, 1988
Days to Decision 118 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
31d slower than avg
Panel avg: 87d · This submission: 118d
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 K881868.
LIQUID CHROMATOGRAPHY COLUMNS
K894141 · Supelco, Inc. · Aug 1989
LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE
K884403 · Supelco, Inc. · Dec 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
LIQUID CHROMATOGRAPHY COLUMNS
K861633 · Supelco, Inc. · May 1986