Cleared Traditional

K955680 - SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE

Also marketed or referenced as:
LONG CUFFED

K955680 is the FDA 510(k) clearance for SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE by Mallinckrodt Medical. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K955680 · Mallinckrodt Medical · Anesthesiology device
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Mar 1996
Decision
90d
Days
Class 2
Risk

K955680 is an FDA 510(k) clearance for the SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE. 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 March 13, 1996 after a review of 90 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 Mallinckrodt Medical devices

Submission Details

510(k) Number K955680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1995
Decision Date March 13, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 K955680.
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K971267 · Mallinckrodt Medical · Sep 1997
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
K963732 · Mallinckrodt Medical · Jun 1997
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
K962173 · Mallinckrodt Medical · Oct 1996
MALLINCKRODT SHILEY 15MM CAP
K954749 · Mallinckrodt Medical · Jan 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955516 · Boston Medical Products, Inc. · Dec 1995
SUPERSLICK
K952700 · Bivona Medical Technologies · Oct 1995