Cleared Traditional

K936224 - REUSABLE CANNULA TRACHEOSTOMY TUBES

K936224 is the FDA 510(k) clearance for REUSABLE CANNULA TRACHEOSTOMY TUBES by Mallinckrodt Medical Tpi, Inc.. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K936224 · Mallinckrodt Medical Tpi, Inc. · Anesthesiology device
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Aug 1994
Decision
266d
Days
Class 2
Risk

K936224 is an FDA 510(k) clearance for the REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Mallinckrodt Medical Tpi, Inc. (Irvine, US). The FDA issued a Cleared decision on August 30, 1994 after a review of 266 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 Tpi, Inc. devices

Submission Details

510(k) Number K936224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1993
Decision Date August 30, 1994
Days to Decision 266 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
126d slower than avg
Panel avg: 140d · This submission: 266d
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 60
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K936224.
SUPERSLICK
K952700 · Bivona Medical Technologies · Oct 1995
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
K945513 · Mallinckrodt Medical · Jan 1995
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178 · Bivona Medical Technologies · Oct 1994
SALINE SOLUTION-STERILE
K933412 · Trinity Laboratories, Inc. · Oct 1993
TRACHEOSTOMY CARE TRAY
K923156 · Orion Life Systems, Inc. · Aug 1993
TRACHEOSTOMY CARE KIT (STERILE)
K925020 · Customed, Inc. · Jul 1993