# K142971: AMT Bridle - Nasal Tube Retention System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: May 26, 2015 after 224 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030784 (2004). 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)
- K030784: Nasogastric Bridle System with Magnetic Retrieval, Applied Medical Technology, Inc. (2004) Summary page 4.

## Recalls of this device
- Jan 19, 2017 · Class III · Z-1223-2017: Expired expiration dates are listed on the pouches.
- Jan 19, 2017 · Class III · Z-1224-2017: Expired expiration dates are listed on the pouches.

## Indications for use
The AMT Bridle - Nasal Tube Retention System is indicated to prevent inadvertent displacement or removal of Nasogastric/Nasointestinal (NG/NI) tubes.

Source page: https://510kreport.com/device/K142971
Methodology: https://510kreport.com/methodology