Cleared Traditional

K133004 - VENTED MILLEX -GV, CATHIVEX -GV (FDA 510(k) Clearance)

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

K133004 · Merck Millipore , Ltd. · Anesthesiology device
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Mar 2014
Decision
183d
Days
Class 2
Risk

K133004 is an FDA 510(k) clearance for the VENTED MILLEX -GV, CATHIVEX -GV. Classified as Filter, Conduction, Anesthetic (product code BSN), Class II - Special Controls.

Submitted by Merck Millipore , Ltd. (Temecula, US). The FDA issued a Cleared decision on March 27, 2014 after a review of 183 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 Merck Millipore , Ltd. devices

Submission Details

510(k) Number K133004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2013
Decision Date March 27, 2014
Days to Decision 183 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 139d · This submission: 183d
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.