Cleared Special

K013988 - MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013988 · Millipore Corp. · Anesthesiology device
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Apr 2002
Decision
121d
Days
Class 2
Risk

K013988 is an FDA 510(k) clearance for the MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R. Classified as Filter, Conduction, Anesthetic (product code BSN), Class II - Special Controls.

Submitted by Millipore Corp. (Bedford, US). The FDA issued a Cleared decision on April 4, 2002 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5130 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Millipore Corp. devices

Submission Details

510(k) Number K013988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date April 04, 2002
Days to Decision 121 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 139d · This submission: 121d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BSN Filter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.