Cleared Traditional

K962173 - SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES

K962173 is an FDA 510(k) clearance for SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES, manufactured by Mallinckrodt Medical. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K962173 · Mallinckrodt Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
121d
Days
Class 2
Risk

K962173 is an FDA 510(k) clearance for the SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES. 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 October 4, 1996 after a review of 121 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

FDA 510(k) Submission Details - K962173

510(k) Number K962173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1996
Decision Date October 04, 1996
Days to Decision 121 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
19d faster than avg
Panel avg: 140d · This submission: 121d
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 90
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K962173.
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
K962175 · Smiths Industries Medical Systems, Inc. · Jan 1997
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE
K962714 · Passy-Muir, Inc. · Oct 1996
TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
K962078 · Continental Medical Laboratories, Inc. · Oct 1996
TRACHEOSTOMY TUBES TRACOE-FLEX
K961449 · Tracoe Medical GmbH · Sep 1996
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
K955564 · Rusch, Inc. · Jun 1996
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
K960429 · Smiths Industries Medical Systems, Inc. · May 1996