Cleared Traditional

K062104 - TALKING TRACH

K062104 is an FDA 510(k) clearance for TALKING TRACH, manufactured by Engineered Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K062104 · Engineered Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
270d
Days
Class 2
Risk

K062104 is an FDA 510(k) clearance for the TALKING TRACH. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Engineered Medical Systems, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on April 20, 2007 after a review of 270 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.

FDA 510(k) Submission Details - K062104

510(k) Number K062104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date April 20, 2007
Days to Decision 270 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
130d slower than avg
Panel avg: 140d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 82
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K062104.
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K073702 · Lazarus Medical, LLC · Jun 2008
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
K060945 · Smiths Medical International · Jun 2006
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K051587 · Tracoe Medical GmbH · Oct 2005
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K050379 · Cs Medical, Inc. · Jul 2005