Cleared Traditional

K972546 - RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY T...

K972546 is the FDA 510(k) clearance for RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY T... by Rusch Intl.. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K972546 · Rusch Intl. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
280d
Days
Class 2
Risk

K972546 is an FDA 510(k) clearance for the RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on April 14, 1998 after a review of 280 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 Rusch Intl. devices

Submission Details

510(k) Number K972546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1997
Decision Date April 14, 1998
Days to Decision 280 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
140d slower than avg
Panel avg: 140d · This submission: 280d
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 K972546.
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 TRACHEOFIX-SET
K972423 · Rusch Intl. · Feb 1998
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
K964056 · Rusch Intl. · Oct 1997
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K971267 · Mallinckrodt Medical · Sep 1997