Cleared Traditional

K110631 - VENNER TRACHEAL SEAL MONITOR

K110631 is an FDA 510(k) clearance for VENNER TRACHEAL SEAL MONITOR, manufactured by Venner Medical (Singapore) Pte, Ltd.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K110631

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
Combination Product No
PCCP Authorized No
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.

BSK Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K110631.
AG GUFFILL
K122721 · Hospitech Respiration , Ltd. · May 2013
SPIRTIUS CUFF INFLATION SYRINGE
K112915 · Spiritus Technologies, LLC · May 2012
PILOT TUBE REPAIR KIT
K113644 · Instrumentation Industries, Inc. · Jan 2012
CUFF SENTRY
K102674 · Ventlab Corp. · Jul 2011
PILOT TUBE REPAIR KIT
K973755 · Instrumentation Industries, Inc. · Dec 1997
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046 · Rusch Intl. · Apr 1995