Cleared Traditional

VENNER TRACHEAL SEAL MONITOR (K110631) - FDA 510(k) Clearance

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

K110631 · Venner Medical (Singapore) Pte, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
7d slower than avg
Panel avg: 139d · 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 38
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K110631.
CuffGuard
K243562 · Idmed · Aug 2025
CuffTrek
K242642 · Shanghai Longmann Tech Co., Ltd. · Mar 2025
TrachCuff Cuff Controller
K220854 · Aw Technologies Aps · Apr 2023
AG100s
K221477 · Hospitech Respiration , Ltd. · Dec 2022
Puritan Bennett Cuff Pressure Manager
K202874 · Covidien, LLC · Jan 2021
Cuffix
K192611 · Biovo Technologies , Ltd. · Aug 2020