Cleared Traditional

K023892 - MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (FDA 510(k) Clearance)

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

K023892 · Millipore Corp. · Anesthesiology device
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Jan 2003
Decision
56d
Days
Class 2
Risk

K023892 is an FDA 510(k) clearance for the MILLEX VV, GV, AND HV SYRINGE FILTER UNITS. 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 January 17, 2003 after a review of 56 days - a notably fast clearance 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: 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 Millipore Corp. devices

Submission Details

510(k) Number K023892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2002
Decision Date January 17, 2003
Days to Decision 56 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
83d faster than avg
Panel avg: 139d · This submission: 56d
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.