Cleared Traditional

PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA (K963732) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963732 · Mallinckrodt Medical · Anesthesiology device
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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
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 139d · 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 16
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K963732.
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
K093469 · Cook, Inc. · Jan 2010
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148 · Cook, Inc. · Oct 2007
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044 · Cook, Inc. · Jul 2004
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435 · Shiley, Inc. · Oct 1990
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K890194 · Shiley, Inc. · Jul 1989
SHILEY FENESTRATED LOW PRESS. CUFFED
K812302 · Shiley, Inc. · Sep 1981