# K140097: Amt Endotracheal Tube Bridle Retention System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Sep 24, 2014 after 253 days
- Product code: CBH (Device, Fixation, Tracheal Tube)
- Device class: 1
- Regulation: 21 CFR 868.5770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K140097
Methodology: https://510kreport.com/methodology