510(k) · Cleared
ClearedAgento I.C. Silver-Coated Endotracheal Tube (Ihvlp)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Mar 25, 2008 as substantially equivalent to K071365 (C.R. Bard, Inc., 2007) after a 61-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Mar 25, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071365 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK071365 Agento I.C. Silver-Coated Endotracheal TubeC.R. Bard, Inc. · 2007
- This deviceK080170 Agento I.C. Silver-Coated Endotracheal Tube (Ihvlp)C.R. Bard, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071365 | Agento I.C. Silver-Coated Endotracheal Tube | C.R. Bard, Inc. | 2007 | — |
| 0 (this device) | K080170 | Agento I.C. Silver-Coated Endotracheal Tube (Ihvlp) | C.R. Bard, Inc. | 2008 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071365 | Agento I.C. Silver-Coated Endotracheal TubeSummary page 1…Phone (770) 784-6722, Fax (770) 385-4768 Common or usual Endlotracheal tube names Classification name Tube, Tracheal (W/Wo Connector) Predicate devices K071365, Agentorm I.C.® Silver-Coated Endotracheal Tube Intended use and Intended Use indications for use The AgentoTM I.C.* Sil… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (123 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080170 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080170: Agento I.C. Silver-Coated Endotracheal Tube (Ihvlp).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080170
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026