# K080170: Agento I.C. Silver-Coated Endotracheal Tube (Ihvlp)

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 25, 2008 after 61 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
Longest line of descent: 1 generation back to K071365 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071365: Agento I.C. Silver-Coated Endotracheal Tube, C.R. Bard, Inc. (2007) Summary page 1.

## Indications for use
The AgentoTM I.C.® silver-coated intermediate high volume low pressure endotracheal (ET) 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 intermediate high volume low pressure endotracheal (ET) 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/K080170
Methodology: https://510kreport.com/methodology