Cleared Traditional

K961449 - TRACHEOSTOMY TUBES TRACOE-FLEX

K961449 is an FDA 510(k) clearance for TRACHEOSTOMY TUBES TRACOE-FLEX, manufactured by Tracoe Medical GmbH. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K961449 · Tracoe Medical GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
150d
Days
Class 2
Risk

K961449 is an FDA 510(k) clearance for the TRACHEOSTOMY TUBES TRACOE-FLEX. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Tracoe Medical GmbH (Frankfurt/M, DE). The FDA issued a Cleared decision on September 13, 1996 after a review of 150 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 Tracoe Medical GmbH devices

FDA 510(k) Submission Details - K961449

510(k) Number K961449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1996
Decision Date September 13, 1996
Days to Decision 150 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
10d slower than avg
Panel avg: 140d · This submission: 150d
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 65
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K961449.
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
K963732 · Mallinckrodt Medical · Jun 1997
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
K962175 · Smiths Industries Medical Systems, Inc. · Jan 1997
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
K962173 · Mallinckrodt Medical · Oct 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
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE
K955680 · Mallinckrodt Medical · Mar 1996