# K071365: Agento I.C. Silver-Coated Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 6, 2007 after 175 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mallinckrodt Hi-Lo® / Intermediate Hi-Lo Cuffed Tracheal Tubes: named in the summary without a submission number

## Most influential descendants
- K080170: Agento I.C. Silver-Coated Endotracheal Tube (Ihvlp) (2008), 0 descendants of its own

## Indications for use
The AgentoTM I.C.® silver-coated endotracheal tube is indicated for airway management by oral or nasal intubation of the trachea for anesthesia and in cases where duration of intubation is expected to be 24 hours or longer, or may be unpredictable. The AgentoTM I.C.® silver-coated endotracheal tube has been shown to reduce the incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP) in patients intubated for 24 hours or longer from an incidence of 7.5% in patients intubated with uncoated ET tubes to an incidence of 4.8% in patients intubated with the Bard Silver-Coated ET tubes (reduction of 36%) and to delay the time to onset of microbiologically confirmed VAP. For Adults Only

Source page: https://510kreport.com/device/K071365
Methodology: https://510kreport.com/methodology