Cleared Traditional

K022212 - PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS

K022212 is an FDA 510(k) clearance for PORTEX PERCUTANEOUS DILATATIONAL TRACHE..., manufactured by Mentor Medical Limited. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K022212 · Mentor Medical Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
256d
Days
Class 2
Risk

K022212 is an FDA 510(k) clearance for the PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Mentor Medical Limited (Hyth, Kent, GB). The FDA issued a Cleared decision on March 21, 2003 after a review of 256 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 Mentor Medical Limited devices

FDA 510(k) Submission Details - K022212

510(k) Number K022212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2002
Decision Date March 21, 2003
Days to Decision 256 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
116d slower than avg
Panel avg: 140d · This submission: 256d
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 85
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K022212.
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K030787 · Nellcor Puritan Bennett, Inc. · Nov 2003
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
K031057 · Portex, Inc. · Jul 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
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
K000964 · Automatic Liquid Packaging, Inc. · Apr 2000