Cleared Traditional

K963717 - MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963717 · Millipore Corp. · Anesthesiology device
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Jun 1997
Decision
267d
Days
Class 2
Risk

K963717 is an FDA 510(k) clearance for the MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS). 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 June 10, 1997 after a review of 267 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5130 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Millipore Corp. devices

Submission Details

510(k) Number K963717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date June 10, 1997
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 139d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.