510(k) · Cleared
ClearedAmt Endotracheal Tube Bridle Retention System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technology, Inc. · CBH Device, Fixation, Tracheal Tube
Cleared on Sep 24, 2014 after a 253-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 24, 2014
- Review
- 253 days
- Class
- Class I
- Product code
- CBH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All CBH devicesCBH Device, Fixation, Tracheal Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · CBH
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · CBH
Too few CBH 510(k)s in any year since 2007 to give a median.
Recalls per year · CBH
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBH
62in 2025
MAUDE reports naming product code CBH, 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 | 0 | — | 2 | 22 |
| 2008 | 0 | — | 0 | 45 |
| 2009 | 0 | — | 0 | 23 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 35 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 40 |
| 2015 | 0 | — | 0 | 17 |
| 2016 | 0 | — | 0 | 26 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 30 |
| 2020 | 0 | — | 0 | 67 |
| 2021 | 0 | — | 0 | 27 |
| 2022 | 0 | — | 0 | 47 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 4 | 20 |
| 2025 | 0 | — | 0 | 62 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMT Endotracheal Tube Bridle Retention System is indicated for use in the adult population for securing medically prescribed oral endotracheal tubes ranging in size from 7 to 10 mm in diameter. Target areas of use include intensive care, operating room, ambulatory units, endoscopy units, burn units, X-ray, gastroenterology, or any medical setting where oral tubes are placed and pullouts are a problem.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K140097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140097: Amt Endotracheal Tube Bridle Retention System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140097
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026