Cleared Traditional

K031057 - PER-FIT PERCUTANEOUS DILATIONAL TRACHEO...

K031057 is an FDA 510(k) clearance for PER-FIT PERCUTANEOUS DILATIONAL TRACHEO..., manufactured by Portex, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K031057 · Portex, Inc. · Anesthesiology device
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Jul 2003
Decision
106d
Days
Class 2
Risk

K031057 is an FDA 510(k) clearance for the PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Portex, Inc. (Keene, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 106 days - within the typical 510(k) review window.

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 Portex, Inc. devices

FDA 510(k) Submission Details - K031057

510(k) Number K031057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2003
Decision Date July 18, 2003
Days to Decision 106 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
34d faster than avg
Panel avg: 140d · This submission: 106d
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 70
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K031057.
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K051416 · Mallinckrodt Medical · Jun 2005
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
TRACH VOX
K013728 · Engineered Medical Systems · Jul 2002
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
K011210 · Rusch Intl. · Aug 2001