Cleared Traditional

K110631 - VENNER TRACHEAL SEAL MONITOR

K110631 is the FDA 510(k) clearance for VENNER TRACHEAL SEAL MONITOR by Venner Medical (Singapore) Pte, Ltd.. It is a Class 2 Anesthesiology device (product code BSK) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K110631 · Venner Medical (Singapore) Pte, Ltd. · Anesthesiology device
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Jul 2011
Decision
146d
Days
Class 2
Risk

K110631 is an FDA 510(k) clearance for the VENNER TRACHEAL SEAL MONITOR. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Venner Medical (Singapore) Pte, Ltd. (Rockville, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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 Venner Medical (Singapore) Pte, Ltd. devices

Submission Details

510(k) Number K110631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2011
Decision Date July 28, 2011
Days to Decision 146 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
6d slower than avg
Panel avg: 140d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
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.

Regulatory Peers - BSK Cuff, Tracheal Tube, Inflatable

All 18
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K110631.
VORTRAN Cuff Inflator (VCI)
K173914 · Vortran Medical Technology 1, Inc. · May 2018
CUFF PILOT, SURE SEAL
K142103 · Teleflexmedical, Inc. · May 2015
PILOT TUBE REPAIR KIT
K113644 · Instrumentation Industries, Inc. · Jan 2012
PILOT TUBE REPAIR KIT
K973755 · Instrumentation Industries, Inc. · Dec 1997
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046 · Rusch Intl. · Apr 1995
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638 · Instrumentation Industries, Inc. · Nov 1988