Cleared Traditional

K013728 - TRACH VOX

K013728 is an FDA 510(k) clearance for TRACH VOX, manufactured by Engineered Medical Systems. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K013728 · Engineered Medical Systems · Anesthesiology device
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Jul 2002
Decision
263d
Days
Class 2
Risk

K013728 is an FDA 510(k) clearance for the TRACH VOX. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Engineered Medical Systems (Mccordsville, US). The FDA issued a Cleared decision on July 30, 2002 after a review of 263 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 Engineered Medical Systems devices

FDA 510(k) Submission Details - K013728

510(k) Number K013728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2001
Decision Date July 30, 2002
Days to Decision 263 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
123d slower than avg
Panel avg: 140d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOH Device Classification - Class 2, Special Controls

Product Code JOH Tube Tracheostomy And Tube Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - JOH Tube Tracheostomy And Tube Cuff

All 61
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K013728.
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044 · Cook, Inc. · Jul 2004
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K030787 · Nellcor Puritan Bennett, Inc. · Nov 2003
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
K023918 · Rusch Intl. · Mar 2003
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
K011210 · Rusch Intl. · Aug 2001
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
K972546 · Rusch Intl. · Apr 1998
RUSCH TRACHEOFIX-SET
K972423 · Rusch Intl. · Feb 1998