Cleared Traditional

K936224 - REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS

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

K936224 · Mallinckrodt Medical Tpi, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K936224

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.

JOH Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K936224.
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
K945513 · Mallinckrodt Medical · Jan 1995
EUROMEDICAL POLY TRACHEOTOMY TUBE
K945874 · Regulatory & Marketing Services, Inc. · Dec 1994
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178 · Bivona Medical Technologies · Oct 1994
PERCUTANEOUS TRACHEOSTOMY KIT
K936133 · Smiths Industries Medical Systems, Inc. · Mar 1994
TRACHEOSTOMY CARE TRAY
K932016 · Clinipad Corp. · Nov 1993
SALINE SOLUTION-STERILE
K933412 · Trinity Laboratories, Inc. · Oct 1993