Cleared Traditional

K071365 - AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE

K071365 is an FDA 510(k) clearance for AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE, manufactured by C.R. Bard, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K071365 · C.R. Bard, Inc. · Anesthesiology device
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Nov 2007
Decision
175d
Days
Class 2
Risk

K071365 is an FDA 510(k) clearance for the AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on November 6, 2007 after a review of 175 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K071365

510(k) Number K071365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2007
Decision Date November 06, 2007
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 140d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 131
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K071365.
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
K081086 · Smiths Medical Asd, Inc. · Aug 2008
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
K080821 · Kimberly-Clark Corp. · Apr 2008
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
K080170 · C.R. Bard, Inc. · Mar 2008
AMSINO ENDOTRACHEAL TUBE
K050785 · Amsino International, Inc. · Jul 2005
RUSCH EASY TUBE
K043205 · Teleflex Medical · Jan 2005
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003