Cleared Traditional

K043160 - TRACOE PHON ASSIST I - SPEAKING VALVES

K043160 is an FDA 510(k) clearance for TRACOE PHON ASSIST I - SPEAKING VALVES, 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 95-day FDA review.

K043160 · Tracoe Medical GmbH · Anesthesiology device
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Feb 2005
Decision
95d
Days
Class 2
Risk

K043160 is an FDA 510(k) clearance for the TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T.... Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Tracoe Medical GmbH (Westborough, US). The FDA issued a Cleared decision on February 18, 2005 after a review of 95 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 Tracoe Medical GmbH devices

FDA 510(k) Submission Details - K043160

510(k) Number K043160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2004
Decision Date February 18, 2005
Days to Decision 95 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 140d · This submission: 95d
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 64
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K043160.
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
K081440 · Smiths Medical Asd, Inc. · Sep 2008
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148 · Cook, Inc. · Oct 2007
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K051416 · Mallinckrodt Medical · Jun 2005
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044 · Cook, Inc. · Jul 2004
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K030787 · Nellcor Puritan Bennett, Inc. · Nov 2003
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
K023918 · Rusch Intl. · Mar 2003