Cleared Traditional

K963732 - PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY ...

K963732 is the FDA 510(k) clearance for PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY ... by Mallinckrodt Medical. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K963732 · Mallinckrodt Medical · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jun 1997
Decision
282d
Days
Class 2
Risk

K963732 is an FDA 510(k) clearance for the PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUF.... Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on June 26, 1997 after a review of 282 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 Mallinckrodt Medical devices

Submission Details

510(k) Number K963732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1996
Decision Date June 26, 1997
Days to Decision 282 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
142d slower than avg
Panel avg: 140d · This submission: 282d
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 59
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K963732.
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
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
K962173 · Mallinckrodt Medical · Oct 1996
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE
K955680 · Mallinckrodt Medical · Mar 1996
MALLINCKRODT SHILEY 15MM CAP
K954749 · Mallinckrodt Medical · Jan 1996