Cleared Traditional

K173914 - VORTRAN Cuff Inflator (VCI)

K173914 is an FDA 510(k) clearance for VORTRAN Cuff Inflator (VCI), manufactured by Vortran Medical Technology 1, Inc.. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K173914 · Vortran Medical Technology 1, Inc. · Anesthesiology device
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May 2018
Decision
154d
Days
Class 2
Risk

K173914 is an FDA 510(k) clearance for the VORTRAN Cuff Inflator (VCI). Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on May 25, 2018 after a review of 154 days - an extended review cycle.

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 Vortran Medical Technology 1, Inc. devices

FDA 510(k) Submission Details - K173914

510(k) Number K173914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2017
Decision Date May 25, 2018
Days to Decision 154 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
14d slower than avg
Panel avg: 140d · This submission: 154d
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 18
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K173914.
Pylant Monitor
K191858 · Kal-Med, LLC · Feb 2020
Accucuff Cuff Pressure Indicator
K182548 · Tianjin Medis Medical Device Co., Ltd. · Jan 2019
AG 100s
K180991 · Hospitech Respiration , Ltd. · Oct 2018
IntelliCuff
K150893 · Hamilton Medical AG · Jan 2016
CUFF PILOT, SURE SEAL
K142103 · Teleflexmedical, Inc. · May 2015
PILOT TUBE REPAIR KIT
K113644 · Instrumentation Industries, Inc. · Jan 2012