Cleared Traditional

K023918 - RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS

K023918 is the FDA 510(k) clearance for RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS by Rusch Intl.. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K023918 · Rusch Intl. · Anesthesiology device
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Mar 2003
Decision
123d
Days
Class 2
Risk

K023918 is an FDA 510(k) clearance for the RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on March 28, 2003 after a review of 123 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 Rusch Intl. devices

Submission Details

510(k) Number K023918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2002
Decision Date March 28, 2003
Days to Decision 123 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
17d faster than avg
Panel avg: 140d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 57
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K023918.
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
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