Cleared Traditional

CUFF SENTRY (K102674) - FDA 510(k) Clearance

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

K102674 · Ventlab Corp. · Anesthesiology device
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Jul 2011
Decision
309d
Days
Class 2
Risk

K102674 is an FDA 510(k) clearance for the CUFF SENTRY. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Ventlab Corp. (Mocksville, US). The FDA issued a Cleared decision on July 22, 2011 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ventlab Corp. devices

Submission Details

510(k) Number K102674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2010
Decision Date July 22, 2011
Days to Decision 309 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
169d slower than avg
Panel avg: 140d · This submission: 309d
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 12
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K102674.
Accucuff Cuff Pressure Indicator
K182548 · Tianjin Medis Medical Device Co., Ltd. · Jan 2019
AG 100s
K180991 · Hospitech Respiration , Ltd. · Oct 2018
VORTRAN Cuff Inflator (VCI)
K173914 · Vortran Medical Technology 1, Inc. · May 2018
RESPIRONICS PR VALVE
K833327 · Respironics, Inc. · Nov 1983
SHILEY PRESSURE RELIEF ADAPTER PRA
K792265 · Shiley, Inc. · Nov 1979