Cleared Special

K080170 - AGENTO I.C. SILVER-COATED ENDOTRACHEAL ...

K080170 is an FDA 510(k) clearance for AGENTO I.C. SILVER-COATED ENDOTRACHEAL ..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Special 510(k) pathway after a 61-day FDA review.

K080170 · C.R. Bard, Inc. · Anesthesiology device
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Mar 2008
Decision
61d
Days
Class 2
Risk

K080170 is an FDA 510(k) clearance for the AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP). 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 March 25, 2008 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K080170

510(k) Number K080170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2008
Decision Date March 25, 2008
Days to Decision 61 days
Submission Type Special
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
79d faster than avg
Panel avg: 140d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

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 K080170.
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K082520 · Mallinckrodt Medical · Oct 2008
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
K071365 · C.R. Bard, Inc. · Nov 2007
AMSINO ENDOTRACHEAL TUBE
K050785 · Amsino International, Inc. · Jul 2005
RUSCH EASY TUBE
K043205 · Teleflex Medical · Jan 2005